Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:29 AM
Study NCT ID:
NCT05443594
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2022-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany', 'Italy', 'Netherlands', 'Switzerland', 'United Kingdom'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Thomas.Stoltz@bsci.com', 'phone': '651-582-4000', 'title': 'Thomas Stoltz', 'organization': 'Boston Scientific'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Through Day 360', 'eventGroups': [{'id': 'EG000', 'title': 'Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects', 'description': 'PHASE 1 only\n\nPhase 1: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter.', 'otherNumAtRisk': 260, 'deathsNumAtRisk': 260, 'otherNumAffected': 82, 'seriousNumAtRisk': 260, 'deathsNumAffected': 0, 'seriousNumAffected': 44}, {'id': 'EG001', 'title': 'Pulsed Field Ablation (Phase 2) Non-Roll In Treatment Subjects', 'description': 'Phase 2 only\n\nPhase 2: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter and FARAPOINT PFA Catheter for cavo-tricuspid isthmus (CTI) ablation.', 'otherNumAtRisk': 255, 'deathsNumAtRisk': 255, 'otherNumAffected': 76, 'seriousNumAtRisk': 255, 'deathsNumAffected': 2, 'seriousNumAffected': 53}], 'otherEvents': [{'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AV block (permanent)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial tachycardia/ Other SVT(AVRT, AVNRT, EAT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain - Ischemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue/ weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension/ hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple heart failure symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral edema - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Localized infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Physical trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': '1st degree AV block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse reaction - Medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina/Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial flutter, not specified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising access site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular Accident (CVA) - Hemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain - Ischemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever and/or virus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid volume overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Failure symptoms - Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemolysis (Laboratory confirmed)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inadequate healing of incision site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-Sustained Ventricular Tachycardia (NSVT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-symptomatic pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oozing/Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain (Non-cardiovascular)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain cardiovascular (Non-ischemic)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Phrenic nerve injury temporary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post procedure infection/sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post procedure wound discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post -surgical infection (<=30 days post implant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post surgical wound discomfort/bruising/swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-surgical pocket hemorrhage/bleeding/drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure related Abnormal labs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure related Allergic reactions/Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure related Anesthesia/Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure related Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure related Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure related Genitourinary/Renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure related Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure related Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure related Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure related Neurological (Non-TIA, non-stroke, dysphagia, speech disturbance/dysarthria)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure related Pulmonary (including cough, hemoptysis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Symptomatic pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vasovagal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual blurring/disturbances, Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': '2nd degree AV block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal laboratory values', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse reaction-Medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial tachycardia/ Other SVT (AVRT, AVNRT, EAT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular Accident (CVA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular Accident (CVA)- Hemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery injury/ spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbation of existing condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid volume overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma - Unrelated procedure/device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Localized infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Physical Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion - unrelated procedure/ device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post procedure infection/ sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure related Anesthesia/ sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure related Genitourinary/ renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure related heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure related hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure related Neurological (Non-TIA, non-stroke, dysphagia, speech disturbance/ dysarthria)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure related Pulmonary (including cough, hemoptysis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ST segment elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Valvular damage/ valvular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AV block (Transient)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Embolism - Air', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Head, Eyes, Ears, Nose, Throat (HEENT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemolysis (laboratory confirmed)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemolysis high suspicion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension/Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension/Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Impaired Mobility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection - Unrelated procedure/device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Major bleeding/Hemorrhage requiring transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial perforation with tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial effusion - Unrelated procedure/device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-surgical pocket hemorrhage/bleeding/drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure related Abnormal labs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure related Fatigue/Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure related Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedure related Renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vasovagal reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Safety Endpoint (PSE): Event Rate of Safety Events Post Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects', 'description': 'PHASE 1 only\n\nPhase 1: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter.'}, {'id': 'OG001', 'title': 'Pulsed Field Ablation (Phase 2) Non-Roll In Treatment Subjects', 'description': 'Phase 2 only\n\nPhase 2: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter and FARAPOINT PFA Catheter for cavo-tricuspid isthmus (CTI) ablation.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'comment': 'One sided confidence interval', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '5.1'}, {'value': '2.4', 'comment': 'One sided confidence interval', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': '5.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Phase 1 Index Procedure through 360 Days | Phase 2 Index Procedure through 90 Days (per protocol Primary Safety Endpoint requirements)', 'description': 'Phase 1:\n\nThrough 7 Days:\n\n* Myocardial infarction\n* Stroke\n* Transient Ischemic Attack (TIA)\n* Peripheral or organ thromboembolism\n* Pulmonary edema\n* Unresolved phrenic nerve palsy / paresis\n* Vascular access complications\n* Heart block\n* Gastric motility / pyloric spasm disorders\n\nThrough 30 Days:\n\n* Cardiac tamponade / perforation\n* Pericarditis\n\nThrough 360 Days Post-Procedure:\n\n* PV stenosis\n* Atrio-esophageal fistula\n\nPhase 2\n\nThrough 7 Days:\n\n* Myocardial infarction\n* Stroke\n* Transient Ischemic Attack (TIA)\n* Peripheral or organ thromboembolism\n* Pulmonary edema\n* Unresolved phrenic nerve palsy / paresis\n* Vascular access complications\n* Heart block\n* Gastric motility / pyloric spasm disorders\n\nThrough 30 Days:\n\n* Death\n* Cardiac tamponade / perforation\n* Pericarditis\n* Any PFA system related PFA procedure-related cardiovascular or pulmonary adverse event\n\nThrough 90 Days:\n\n* PV stenosis\n* Atrio-esophageal fistula', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Adverse Events reported for subjects were reviewed and adjudicated for meeting Safety Endpoint criteria by an independent physician Clinical Events Committee.'}, {'type': 'PRIMARY', 'title': 'Primary Effectiveness Endpoint: Treatment Success Rate Through Day 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects', 'description': 'PHASE 1 only\n\nPhase 1: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter.'}, {'id': 'OG001', 'title': 'Pulse Field Ablation (Phase 2) Non-Roll In Treatment Subject', 'description': 'Phase 2 only\n\nPhase 2: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter and FARAPOINT PFA Catheter for cavo-tricuspid isthmus (CTI) ablation.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.5', 'comment': 'One-sided confidence interval', 'groupId': 'OG000', 'lowerLimit': '57.3', 'upperLimit': 'NA'}, {'value': '73.4', 'comment': 'One-sided confidence interval', 'groupId': 'OG001', 'lowerLimit': '67.5', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-Blanking Period: Day 90 through Day 360', 'description': 'Includes both Acute Procedural Success and Chronic Success through Day 360.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Phase 1 includes all Non-Roll in Treatment subjects. Phase 2 includes Non-Roll in Treatment subjects who received an Insertable Cardiac Monitor for arrhythmia recurrence monitoring.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Persistent AF Chronic Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects', 'description': 'PHASE 1 only\n\nPhase 1: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter.'}, {'id': 'OG001', 'title': 'Pulsed Field Ablation (Phase 2) Non-Roll In Treatment Subjects', 'description': 'Phase 2 only\n\nPhase 2: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter and FARAPOINT PFA Catheter for cavo-tricuspid isthmus (CTI) ablation.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.2', 'groupId': 'OG000', 'lowerLimit': '58.1', 'upperLimit': '70.1'}, {'value': '73.4', 'groupId': 'OG001', 'lowerLimit': '67.5', 'upperLimit': '78.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-Blanking Period: Day 90 through Day 360', 'description': 'Defined as the freedom from any of the following through the Day 360 Assessment after the Blanking Period, excluding documented CTI-dependent AFL for phase 1 and for Phase 2 excluding documented CTI-dependent AFL if the participant did not have a CTI ablation with a FARAPOINT PFA Catheter:\n\n1. Arrhythmia: Occurrence of any Detectable AF, AFL or AT\n2. Re-ablation: Any re-ablation for AF, AFL or AT\n3. Cardioversion: Any electrical cardioversion for AF, AFL or AT\n4. AAD Use: Use of a Non-Failed Class I / III AAD or amiodarone', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Phase 1 includes all Non-Roll in Treatment subjects. Phase 2 includes Non-Roll in Treatment subjects who received an Insertable Cardiac Monitor for arrhythmia recurrence monitoring.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Persistent AF Acute Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects', 'description': 'PHASE 1 only\n\nPhase 1: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter.'}, {'id': 'OG001', 'title': 'Pulsed Field Ablation (Phase 2) Non-Roll In Treatment Subjects', 'description': 'Phase 2 only\n\nPhase 2: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter and FARAPOINT PFA Catheter for cavo-tricuspid isthmus (CTI) ablation.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100'}, {'value': '99.6', 'groupId': 'OG001', 'lowerLimit': '97.8', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed through Index Ablation Procedure', 'description': '* The isolation of all attempted PVs as clinically assessed at the end of the procedure by entrance block performed with or without adenosine testing, AND\n* The isolation of the left atrial PW as clinically assessed at the end of the procedure, performed with or without adenosine testing, via interrogation by multipolar diagnostic catheter or 3D electroanatomical mapping.\n* Use of an ablation catheter other than the FARAWAVE Pulse Field Ablation Catheter (i.e., use of a non-study catheter) to achieve Pulmonary Vein Isolation and Posterior Wall Isolation.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Phase 1 includes all Non-Roll in Treatment subjects. Phase 2 includes Non-Roll in Treatment subjects who received an Insertable Cardiac Monitor for arrhythmia recurrence monitoring.'}, {'type': 'POST_HOC', 'title': 'Freedom From Documented Symptomatic Recurrence and Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects', 'description': 'PHASE 1 only\n\nPhase 1: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter.'}, {'id': 'OG001', 'title': 'Pulsed Field Ablation (Phase 2) Non-Roll In Treatment Subjects', 'description': 'Phase 2 only\n\nPhase 2: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter and FARAPOINT PFA Catheter for cavo-tricuspid isthmus (CTI) ablation.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.3', 'comment': 'One sided confidence interval', 'groupId': 'OG000', 'lowerLimit': '80.3', 'upperLimit': 'NA'}, {'value': '81.0', 'groupId': 'OG001', 'lowerLimit': '75.5', 'upperLimit': '85.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-Blanking Period: Day 90 through Day 360', 'description': 'Freedom from symptomatic recurrence and intervention is Chronic Treatment Success, as defined for the Primary Effectiveness Endpoint, but excluding failure due to asymptomatic detectable AF, AFL, or AT.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: Freedom from Documented Symptomatic Recurrence and Intervention was a post-hoc analysis for the Phase 1 cohort and a pre-specified analysis for the Phase 2 cohort.\n\nNote: Phase 1 includes all Non-Roll in Treatment subjects. Phase 2 includes Non-Roll in Treatment subjects who received an Insertable Cardiac Monitor for arrhythmia recurrence monitoring.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pulsed Field Ablation (Phase 1)', 'description': 'PHASE 1 only\n\nPhase 1: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter.'}, {'id': 'FG001', 'title': 'Pulse Field Ablation (Phase 2)', 'description': 'Phase 2 only\n\nPhase 2: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter and FARAPOINT PFA Catheter for cavo-tricuspid isthmus (CTI) ablation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '355'}, {'groupId': 'FG001', 'numSubjects': '314'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '325'}, {'groupId': 'FG001', 'numSubjects': '290'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '24'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '515', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects', 'description': 'PHASE 1 only\n\nPhase 1: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter.'}, {'id': 'BG001', 'title': 'Pulsed Field Ablation (Phase 2) Non-Roll In Treatment Subjects', 'description': 'Phase 2 only\n\nPhase 2: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter and FARAPOINT PFA Catheter for cavo-tricuspid isthmus (CTI) ablation.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.2', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '66.7', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '66.4', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '362', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '245', 'groupId': 'BG001'}, {'value': '456', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '209', 'groupId': 'BG000'}, {'value': '241', 'groupId': 'BG001'}, {'value': '450', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Unknown or Not Report', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height (cm)', 'classes': [{'categories': [{'measurements': [{'value': '175.8', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '177.6', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '176.7', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '94.3', 'spread': '19.7', 'groupId': 'BG000'}, {'value': '98', 'spread': '20.3', 'groupId': 'BG001'}, {'value': '96.1', 'spread': '20.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI (kg/m^2)', 'classes': [{'categories': [{'measurements': [{'value': '30.4', 'spread': '5.3', 'groupId': 'BG000'}, {'value': '30.9', 'spread': '5.3', 'groupId': 'BG001'}, {'value': '30.7', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Resting Heart Rate (bpm)', 'classes': [{'categories': [{'measurements': [{'value': '74', 'spread': '18.3', 'groupId': 'BG000'}, {'value': '76.8', 'spread': '18.7', 'groupId': 'BG001'}, {'value': '75.4', 'spread': '18.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'bpm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic Blood Pressure (mmHg)', 'classes': [{'categories': [{'measurements': [{'value': '129.9', 'spread': '16.6', 'groupId': 'BG000'}, {'value': '129.8', 'spread': '16.6', 'groupId': 'BG001'}, {'value': '129.8', 'spread': '16.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic Blood Pressure (mmHg)', 'classes': [{'categories': [{'measurements': [{'value': '77.5', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '77.6', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '77.5', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Left Ventricular Ejection Fraction (%)', 'classes': [{'categories': [{'measurements': [{'value': '57.2', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '56.6', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '56.9', 'spread': '6.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '% blood ejected from the left ventricle', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LA Diameter (cm)', 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '4.3', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '4.3', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LA Volume (mL)', 'classes': [{'categories': [{'measurements': [{'value': '65.1', 'spread': '24.6', 'groupId': 'BG000'}, {'value': '65.5', 'spread': '19.3', 'groupId': 'BG001'}, {'value': '65.2', 'spread': '23.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'NYHA', 'classes': [{'title': 'No Heart Failure', 'categories': [{'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '313', 'groupId': 'BG002'}]}]}, {'title': 'Class I', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}, {'title': 'Class II', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}, {'title': 'Class III', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Class IV', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'New York Heart Association (NYHA) Heart Failure Classification based on the severity of heart failure symptoms as assessed by the clinician - progressively ranging from no heart failure to Class IV heart failure.', 'unitOfMeasure': 'participants'}, {'title': 'CHA₂DS₂-VASc Score', 'classes': [{'categories': [{'title': '1', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}, {'title': '3', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': '4', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': '5', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': '6', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': '7', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '0', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The CHA2DS2-VASc Score for Atrial Fibrillation Stroke Risk - is a point-based system that considers several risk factors, and the total score helps determine the likelihood of stroke (i.e., the stroke risk for patients with atrial fibrillation). The higher the score the higher the risk.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This patient population are the 260 Non-Roll in subjects in Phase 1 and 255 subjects in Phase 2 who received treatment with the PFA System.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-09-27', 'size': 10223885, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-01T16:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 669}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2022-06-29', 'resultsFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2022-06-29', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-09', 'studyFirstPostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of Persistent AF Chronic Success', 'timeFrame': 'Post-Blanking Period: Day 90 through Day 360', 'description': 'Defined as the freedom from any of the following through the Day 360 Assessment after the Blanking Period, excluding documented CTI-dependent AFL for phase 1 and for Phase 2 excluding documented CTI-dependent AFL if the participant did not have a CTI ablation with a FARAPOINT PFA Catheter:\n\n1. Arrhythmia: Occurrence of any Detectable AF, AFL or AT\n2. Re-ablation: Any re-ablation for AF, AFL or AT\n3. Cardioversion: Any electrical cardioversion for AF, AFL or AT\n4. AAD Use: Use of a Non-Failed Class I / III AAD or amiodarone'}, {'measure': 'Rate of Persistent AF Acute Procedural Success', 'timeFrame': 'Assessed through Index Ablation Procedure', 'description': '* The isolation of all attempted PVs as clinically assessed at the end of the procedure by entrance block performed with or without adenosine testing, AND\n* The isolation of the left atrial PW as clinically assessed at the end of the procedure, performed with or without adenosine testing, via interrogation by multipolar diagnostic catheter or 3D electroanatomical mapping.\n* Use of an ablation catheter other than the FARAWAVE Pulse Field Ablation Catheter (i.e., use of a non-study catheter) to achieve Pulmonary Vein Isolation and Posterior Wall Isolation.'}], 'primaryOutcomes': [{'measure': 'Primary Safety Endpoint (PSE): Event Rate of Safety Events Post Procedure', 'timeFrame': 'Phase 1 Index Procedure through 360 Days | Phase 2 Index Procedure through 90 Days (per protocol Primary Safety Endpoint requirements)', 'description': 'Phase 1:\n\nThrough 7 Days:\n\n* Myocardial infarction\n* Stroke\n* Transient Ischemic Attack (TIA)\n* Peripheral or organ thromboembolism\n* Pulmonary edema\n* Unresolved phrenic nerve palsy / paresis\n* Vascular access complications\n* Heart block\n* Gastric motility / pyloric spasm disorders\n\nThrough 30 Days:\n\n* Cardiac tamponade / perforation\n* Pericarditis\n\nThrough 360 Days Post-Procedure:\n\n* PV stenosis\n* Atrio-esophageal fistula\n\nPhase 2\n\nThrough 7 Days:\n\n* Myocardial infarction\n* Stroke\n* Transient Ischemic Attack (TIA)\n* Peripheral or organ thromboembolism\n* Pulmonary edema\n* Unresolved phrenic nerve palsy / paresis\n* Vascular access complications\n* Heart block\n* Gastric motility / pyloric spasm disorders\n\nThrough 30 Days:\n\n* Death\n* Cardiac tamponade / perforation\n* Pericarditis\n* Any PFA system related PFA procedure-related cardiovascular or pulmonary adverse event\n\nThrough 90 Days:\n\n* PV stenosis\n* Atrio-esophageal fistula'}, {'measure': 'Primary Effectiveness Endpoint: Treatment Success Rate Through Day 360', 'timeFrame': 'Post-Blanking Period: Day 90 through Day 360', 'description': 'Includes both Acute Procedural Success and Chronic Success through Day 360.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Persistent Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '40928625', 'type': 'DERIVED', 'citation': 'Matsumoto K, van Bragt KA, Kueffer FJ, Mburu W, Tarakji KG. Indirect treatment comparison of two pulsed field ablation systems for the treatment of persistent atrial fibrillation. J Interv Card Electrophysiol. 2025 Sep 10. doi: 10.1007/s10840-025-02124-6. Online ahead of print.'}, {'pmid': '40306839', 'type': 'DERIVED', 'citation': 'Reddy VY, Gerstenfeld EP, Schmidt B, Nair D, Natale A, Saliba W, Verma A, Sommer P, Metzner A, Turagam M, Weiner S, Champagne J, Garcio-Bolao I, Calkins H, Olson J, Issa Z, Winner M, Su W, Tomassoni G, Kim J, Hook B, Delurgio DB, Gibson DN, Daccarett M, Patel C, Bhalla K, Shehata M, Harding JD, Cheung JW, Raybuck JD, Roelke S, Schwartz T, Sutton BS, Mansour M; ADVANTAGE-AF Investigators. Pulsed Field Ablation for Persistent Atrial Fibrillation: 1-Year Results of ADVANTAGE AF. J Am Coll Cardiol. 2025 May 6;85(17):1664-1678. doi: 10.1016/j.jacc.2025.03.515.'}, {'pmid': '40273320', 'type': 'DERIVED', 'citation': 'Reddy VY, Gerstenfeld EP, Schmidt B, Andrade JG, Nair D, Natale A, Saliba W, Sommer P, Metzner A, Verma A, Hounshell T, Amin A, Gentlesk P, Weiner S, Cuoco FA, Kim J, Turagam MK, Tomassoni G, Patel C, Issa Z, Shehata M, Anderson AM, Stoltz TJ, Raybuck JD, Schwartz T, Sutton BS, Mansour M; ADVANTAGE AF Investigators. Pulsed Field Ablation of Persistent Atrial Fibrillation With Continuous Electrocardiographic Monitoring Follow-Up: ADVANTAGE AF Phase 2. Circulation. 2025 Jul 8;152(1):27-40. doi: 10.1161/CIRCULATIONAHA.125.074485. Epub 2025 Apr 24.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the ADVANTAGE AF Study is to establish the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System (FARAPULSE PFA System) for treatment of drug resistant, symptomatic persistent atrial fibrillation (PersAF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "\\[PHASE 1\\] --------------------------------------------\n\nInclusion Criteria:\n\n1. Age ≥ 18 years of age, or older if specified by local law\n2. Subjects have symptomatic, documented, drug-resistant, Persistent AF, defined as:\n\n a. Documented: at a minimum a physician's note confirming the arrhythmia symptoms and durations AND, within 180 days of Enrollment Date, either: i. A 24-hour continuous ECG recording confirming continuous AF OR ii. Two ECGs from any regulatory cleared rhythm monitoring device showing continuous AF taken at least 7 days apart b. Drug-resistant: effectiveness failure of, intolerance to, or specific contraindication to at least one (1) AAD (Class I or III).\n\n c. Persistent: continuous AF for \\> 7 days and ≤ 365 days\n3. Subjects who are willing and capable of providing informed consent\n4. Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center\n\nExclusion Criteria:\n\n1. Any of the following atrial conditions:\n\n 1. Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter not available, non-indexed volume \\>100 ml (by MRI, CT or TTE report or physician note)\n 2. Any prior atrial endocardial, epicardial or surgical ablation procedure for arrhythmia, other than right sided cavotricuspid isthmus ablation or for right sided SVT\n 3. Current atrial myxoma\n 4. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)\n 5. Current left atrial thrombus\n2. Cardiovascular exclusions - Any of the following CV conditions:\n\n a. History of sustained ventricular tachycardia or any ventricular fibrillation b. AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes c. Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, interatrial baffle, closure device, patch, or patent foramen ovale occluder, LA appendage closure, device or occlusion, active implantable loop recorder or insertable cardiac monitor at the time of ablation d. Valvular disease that is any of the following: i. Symptomatic ii. Causing or exacerbating congestive heart failure iii. Associated with abnormal LV function or hemodynamic measurements e. Hypertrophic cardiomyopathy f. Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty g. Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access h. Rheumatic heart disease i. Congenital heart disease with any clinically significant residual anatomic or conduction abnormality j. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months\n3. Any of the following conditions at baseline (Section7.5):\n\n 1. Heart failure associated with NYHA Class III or IV\n 2. LVEF \\< 40%\n 3. Uncontrolled hypertension (SBP \\> 160 mmHg or DBP \\> 95 mmHg on two (2) BP measurements at baseline assessment\n4. Any of the following events within 90 days of the Consent Date:\n\n 1. Myocardial infarction (MI), unstable angina or coronary intervention\n 2. Any cardiac surgery\n 3. Heart failure hospitalization\n 4. Pericarditis or symptomatic pericardial effusion\n 5. Gastrointestinal bleeding\n 6. Stroke, TIA, or intracranial bleeding\n 7. Any non-neurologic thromboembolic event\n 8. Carotid stenting or endarterectomy\n5. Thrombocytosis, thrombocytopenia, disorder of blood clotting or bleeding diathesis\n6. Contraindication to, or unwillingness to use, systemic anticoagulation\n7. Patients who have not been on anticoagulation therapy for at least 4 weeks prior to the ablation procedure\n8. Women of childbearing potential who are pregnant, lactating, not using medical birth control or who are planning to become pregnant during the anticipated study period\n9. Health conditions that in the investigator's medical opinion would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation, including but not limited to:\n\n 1. Body Mass Index (BMI) \\> 42.0\n 2. Solid organ or hematologic transplant, or currently being evaluated for a transplant\n 3. Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis.\n 4. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen\n 5. Renal insufficiency if an estimated glomerular filtration rate (eGFR) is \\< 30 mL / min / 1.73 m2, or with any history of renal dialysis or renal transplant\n 6. Active malignancy or history of treated malignancy within 24 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma)\n 7. Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration\n 8. Active systemic infection\n 9. COVID-19 disease\n\n i. Current confirmed, active COVID-19 disease ii. Current positive test for SARS-CoV-2 iii. Confirmed COVID-19 disease not clinically resolved at least 3 months prior to the Consent Date j. Uncontrolled diabetes mellitus or a recorded HgbA1c \\> 8.0% in the 90 days prior to the Consent Date k. Untreated diagnosed obstructive sleep apnea with apnea hypopnea index classification of severe (\\>30 pauses per hour)\n10. Predicted life expectancy less than one (1) year\n11. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility\n\n\\[PHASE 2\\] --------------------------------------------\n\nInclusion Criteria:\n\n1. Age ≥ 18 years of age, or older if specified by local law\n2. Subjects have symptomatic, documented, drug-resistant, Persistent AF, defined as:\n\n a. Documented: at a minimum a physician's note confirming the arrhythmia symptoms and durations AND, within 180 days of Enrollment Date, either: i. A 24-hour continuous ECG recording confirming continuous AF OR ii. Two ECGs from any regulatory cleared rhythm monitoring device showing continuous AF taken at least 7 days apart b. Drug-resistant: effectiveness failure of, intolerance to, or specific contraindication to at least one (1) AAD (Class I or III).\n\n c. Persistent: continuous AF for \\> 7 days and ≤ 365 days\n3. Subjects who are willing and capable of providing informed consent\n4. Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center\n\nExclusion Criteria:\n\n1. Any of the following atrial conditions:\n\n 1. Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter not available, non-indexed volume \\>100 ml (by MRI, CT or TTE report or physician note)\n 2. Any prior atrial endocardial, epicardial or surgical ablation procedure for arrhythmia, other than right sided cavotricuspid isthmus ablation or for right sided SVT\n 3. Current atrial myxoma\n 4. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)\n 5. Current left atrial thrombus\n2. Cardiovascular exclusions - Any of the following CV conditions:\n\n 1. History of sustained ventricular tachycardia or any ventricular fibrillation\n 2. AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes\n 3. Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, interatrial baffle, closure device, patch, or patent foramen ovale occluder, LA appendage closure, device or occlusion, active implantable loop recorder or insertable cardiac monitor at the time of ablation\n 4. Valvular disease that is any of the following:\n\n i. Symptomatic ii. Causing or exacerbating congestive heart failure iii. Associated with abnormal LV function or hemodynamic measurements e. Hypertrophic cardiomyopathy f. Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty g. Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access h. Rheumatic heart disease i. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months j. Nitroglycerin intolerance: Known adverse drug reaction to nitroglycerin k. Coronary disease: Known severe non-revascularizable coronary disease l. Stents: Pre-existing right coronary artery stent\n3. Any of the following conditions at baseline (Section7.5):\n\n 1. Heart failure associated with NYHA Class III or IV\n 2. LVEF \\< 40%\n 3. Uncontrolled hypertension (SBP \\> 160 mmHg or DBP \\> 95 mmHg on two (2) BP measurements at baseline assessment\n 4. Ventricular dysfunction: Right ventricular dysfunction\n4. Any of the following events within 90 days of the Consent Date:\n\n 1. Myocardial infarction (MI), unstable angina or coronary intervention\n 2. Any cardiac surgery\n 3. Heart failure hospitalization\n 4. Pericarditis or symptomatic pericardial effusion\n 5. Gastrointestinal bleeding\n 6. Stroke, TIA, or intracranial bleeding\n 7. Any non-neurologic thromboembolic event\n 8. Carotid stenting or endarterectomy\n5. Thrombocytosis, thrombocytopenia, disorder of blood clotting or bleeding diathesis\n6. Contraindication to, or unwillingness to use, systemic anticoagulation\n7. Patients who have not been on anticoagulation therapy for at least 4 weeks prior to the ablation procedure\n8. Women of childbearing potential who are pregnant, lactating, not using medical birth control or who are planning to become pregnant during the anticipated study period\n9. Health conditions that in the investigator's medical opinion would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation, including but not limited to:\n\n 1. Body Mass Index (BMI) \\> 42.0\n 2. Solid organ or hematologic transplant, or currently being evaluated for a transplant\n 3. Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis.\n 4. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen\n 5. Renal insufficiency if an estimated glomerular filtration rate (eGFR) is \\< 30 mL / min / 1.73 m2, or with any history of renal dialysis or renal transplant\n 6. Active malignancy or history of treated malignancy within 24 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma)\n 7. Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration\n 8. Active systemic infection\n 9. COVID-19 disease\n\n i. Current confirmed, active COVID-19 disease ii. Current positive test for SARS-CoV-2 iii. Confirmed COVID-19 disease not clinically resolved at least 3 months prior to the Consent Date j. Uncontrolled diabetes mellitus or a recorded HgbA1c \\> 8.0% in the 90 days prior to the Consent Date k. Untreated diagnosed obstructive sleep apnea with apnea hypopnea index classification of severe (\\>30 pauses per hour) l. Medication Use: Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure\n10. Predicted life expectancy less than one (1) year\n11. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility\n12. Any of the following congenital conditions:\n\n 1. Congenital heart disease: Congenital heart disease with any clinically significant residual anatomic or conduction abnormality\n 2. Methemoglobinemia: History of known congenital methemoglobinemia\n 3. G6PD deficiency: History of known G6PD deficiency\n13. Contraindication to ICM insertion: Patients who cannot tolerate a subcutaneous, chronically-inserted LUX-Dx device\n14. LUX-Dx longevity: Patients with a LUX-Dx device inserted \\> 6 months prior to enrollment with an estimated longevity of less than 1 year"}, 'identificationModule': {'nctId': 'NCT05443594', 'acronym': 'ADVANTAGE AF', 'briefTitle': 'A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation', 'orgStudyIdInfo': {'id': '92836802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulsed Field Ablation (Phase 1)', 'description': 'PHASE 1 only', 'interventionNames': ['Device: Phase 1: FARAPULSE Ablation System']}, {'type': 'EXPERIMENTAL', 'label': 'Pulsed Field Ablation (Phase 2)', 'description': 'PHASE 2 only', 'interventionNames': ['Device: Phase 2: FARAPULSE Ablation System']}], 'interventions': [{'name': 'Phase 1: FARAPULSE Ablation System', 'type': 'DEVICE', 'description': 'PHASE 1: Pulsed Field Ablation to isolate the Pulmonary Veins and Posterior Wall using the FARAPULSE Ablation System.', 'armGroupLabels': ['Pulsed Field Ablation (Phase 1)']}, {'name': 'Phase 2: FARAPULSE Ablation System', 'type': 'DEVICE', 'description': 'PHASE 2: Pulsed Field Ablation to isolate the Pulmonary Veins, Posterior Wall and Cavo-Tricuspid Isthmus using the FARAPULSE Ablation System.', 'armGroupLabels': ['Pulsed Field Ablation (Phase 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35243', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Grandview Medical Center-Hospital', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center Phoenix-Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arrhythmia Research Group-Research Facility', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Memorial Hospital-Hospital', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars - 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