Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-02 @ 5:52 AM
Study NCT ID:
NCT03650556
Status:
COMPLETED
Last Update Posted:
2022-04-27
First Post:
2018-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-02-10', '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': 'amber.miller@abbott.com', 'phone': '(612) 413-7236', 'title': 'Amber Miller', 'organization': 'Abbott Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '15 months', 'description': 'An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.', 'eventGroups': [{'id': 'EG000', 'title': 'Enrolled', 'description': 'A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria', 'otherNumAtRisk': 224, 'deathsNumAtRisk': 224, 'otherNumAffected': 29, 'seriousNumAtRisk': 224, 'deathsNumAffected': 2, 'seriousNumAffected': 59}], 'otherEvents': [{'term': 'Air Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain/Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis/Thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient Ischemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular Access Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular Bleeding/Local Hematoma/Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Volume Overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Congestive Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated Troponin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Esophageal Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatohepatomegaly With Elevated Liver Enzymes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Jaw Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Shoulder Blade/ Arm Pit Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Trochanteric Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding/Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular Accident/Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary Artery Thrombosis/Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elective Procedure/Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Failure/Pump Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Decompensation/Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Compromise/Decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope/Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Valve Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Volume Overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Ischemic Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bowel Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Colon Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture of Humerous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower GI Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pelvic Inflammatory Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Penile Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal and Vaginal Prolapse Repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Right Hip Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sick Sinus Symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sudden Cardiac Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain/Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Perforation or Tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Jaw and Neck Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Subjects With a Device and/or Procedure-related SAE.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled', 'description': 'A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days of initial or repeat procedure performed ≤180 days of initial procedure', 'description': 'Rate of subjects with a device and/or procedure-related SAE with onset within 7-days of any ablation procedure that used the investigational device.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for the primary safety endpoint is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment and who have completed their 7-day follow-up visit; or crossed the end of the 7-day visit window without the visit but with a primary safety endpoint event'}, {'type': 'PRIMARY', 'title': 'Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled', 'description': 'A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '15 months', 'description': 'The following events were considered a failure for AF/AFL/AT recurrence:\n\n* If AF/AFL/AT recurrence (\\>30 second episode) occurred at any time after the therapy consolidation period (\\>180 days after the initial procedure), or\n* If the subject required a repeat procedure for the treatment of AF after the therapy consolidation period, the subject was considered an effectiveness endpoint failure regardless of documentation of a \\>30 second AF/AFL/AT episode, or\n* If the subject required a second repeat procedure at any time after the initial procedure, or\n* If the subject required a new AAD or a previously failed AAD at a dose greater than the highest ineffective historical dose for AF after the therapy consolidation period, or\n* If the subject required a cardioversion (electrical or pharmacological) for the treatment of AF after the therapy consolidation period, or\n* If the subject had a continuous atrial arrhythmia throughout a 12-lead ECG recording after the the', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for the primary effectiveness endpoint is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment and who have completed their 15-month ECG, TTM, and/or 24-hour Holter assessment; or crossed the end of the 15-month visit window without the ECG, TTM and/or 24-hour Holter assessment but with a prior primary effectiveness endpoint event.'}, {'type': 'SECONDARY', 'title': 'Acute Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled', 'description': 'A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '219', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediate post procedure', 'description': 'Percent of subjects who achieve acute procedural success defined as confirmation of entrance block in all pulmonary veins', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment'}, {'type': 'SECONDARY', 'title': '15-month Success Off of Antiarrhythmic Drugs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ablation', 'description': 'Pulmonary vein isolation by radiofrequency ablation treatment TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) in the persistent AF population.\n\nTactiCath™ Contact Force Ablation Catheter, Sensor Enabled™: Ablation procedure for Persistent AF'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '15 months', 'description': 'Percent of subjects off all AADs taken to treat AF/AFL/AT who achieve15-month success, defined as freedom from documented AF/AFL/AT recurrence (episodes \\>30 seconds) during the 9-month period following the blanking and therapy consolidation periods.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment and who have completed their 15-month ECG, TTM, and/or 24-hour Holter assessment; or crossed the end of the 15-month visit window without the ECG, TTM and/or 24-hour Holter assessment but with a prior primary effectiveness endpoint event.'}, {'type': 'SECONDARY', 'title': '15 Month Single Procedure Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ablation', 'description': 'Pulmonary vein isolation by radiofrequency ablation treatment TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) in the persistent AF population.\n\nTactiCath™ Contact Force Ablation Catheter, Sensor Enabled™: Ablation procedure for Persistent AF'}], 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '15 months', 'description': 'Percent of subjects who achieve 15-month single procedure success, defined as freedom from documented AF/AFL/AT recurrence (episodes \\>30 seconds) during the 9-month period following the blanking and therapy consolidation periods after a single ablation procedure. Any repeat ablation procedure required by the subject at any time was deemed an effectiveness failure in this analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment and who have completed their 15-month ECG, TTM, and/or 24-hour Holter assessment; or crossed the end of the 15-month visit window without the ECG, TTM and/or 24-hour Holter assessment but with a prior primary effectiveness endpoint event.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enrolled', 'description': 'A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '224'}]}, {'type': 'Ablation Procedure', 'achievements': [{'groupId': 'FG000', 'numSubjects': '223'}]}, {'type': 'Pre-Discharge', 'achievements': [{'groupId': 'FG000', 'numSubjects': '223'}]}, {'type': '7-day Follow-Up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '223'}]}, {'type': '3-month Follow-Up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '210'}]}, {'type': '6-month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}]}, {'type': '12-month Follow-Up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '189'}]}, {'type': '15-month Follow-Up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Subject did not complete follow-up but did not meet criteria for lost-to-follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Enrolled, but no ablation performed-investigational catheter was not inserted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria', 'preAssignmentDetails': 'One subject was withdrawn after meeting enrollment criteria but prior to procedure with the investigational device.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ablation', 'description': 'All enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.4', 'spread': '10.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '154', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '209', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '213', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '209', 'groupId': 'BG000'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-14', 'size': 9570084, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-01-18T10:17', 'hasProtocol': True}, {'date': '2020-05-27', 'size': 2144026, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-02-10T14:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-01', 'studyFirstSubmitDate': '2018-08-01', 'resultsFirstSubmitDate': '2022-01-18', 'studyFirstSubmitQcDate': '2018-08-26', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-01', 'studyFirstPostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Subjects With a Device and/or Procedure-related SAE.', 'timeFrame': 'Within 7 days of initial or repeat procedure performed ≤180 days of initial procedure', 'description': 'Rate of subjects with a device and/or procedure-related SAE with onset within 7-days of any ablation procedure that used the investigational device.'}, {'measure': 'Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence.', 'timeFrame': '15 months', 'description': 'The following events were considered a failure for AF/AFL/AT recurrence:\n\n* If AF/AFL/AT recurrence (\\>30 second episode) occurred at any time after the therapy consolidation period (\\>180 days after the initial procedure), or\n* If the subject required a repeat procedure for the treatment of AF after the therapy consolidation period, the subject was considered an effectiveness endpoint failure regardless of documentation of a \\>30 second AF/AFL/AT episode, or\n* If the subject required a second repeat procedure at any time after the initial procedure, or\n* If the subject required a new AAD or a previously failed AAD at a dose greater than the highest ineffective historical dose for AF after the therapy consolidation period, or\n* If the subject required a cardioversion (electrical or pharmacological) for the treatment of AF after the therapy consolidation period, or\n* If the subject had a continuous atrial arrhythmia throughout a 12-lead ECG recording after the the'}], 'secondaryOutcomes': [{'measure': 'Acute Procedural Success', 'timeFrame': 'Immediate post procedure', 'description': 'Percent of subjects who achieve acute procedural success defined as confirmation of entrance block in all pulmonary veins'}, {'measure': '15-month Success Off of Antiarrhythmic Drugs', 'timeFrame': '15 months', 'description': 'Percent of subjects off all AADs taken to treat AF/AFL/AT who achieve15-month success, defined as freedom from documented AF/AFL/AT recurrence (episodes \\>30 seconds) during the 9-month period following the blanking and therapy consolidation periods.'}, {'measure': '15 Month Single Procedure Success', 'timeFrame': '15 months', 'description': 'Percent of subjects who achieve 15-month single procedure success, defined as freedom from documented AF/AFL/AT recurrence (episodes \\>30 seconds) during the 9-month period following the blanking and therapy consolidation periods after a single ablation procedure. Any repeat ablation procedure required by the subject at any time was deemed an effectiveness failure in this analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Persistent Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for use in cardiac electrophysiological mapping and for the treatment of drug-refractory, recurrent symptomatic persistent atrial fibrillation (AF) when used in conjunction with a compatible radiofrequency (RF) generator and three-dimensional mapping system. This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the TactiCath SE ablation catheter for the treatment of drug refractory, symptomatic persistent atrial fibrillation in the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient must provide written informed consent prior to any clinical investigation related procedure.\n2. Documented symptomatic persistent AF, which is defined as continuous AF sustained beyond 7-days and less than 1-year that is documented by (1) a physician's note and (2) a 24-hour Holter within 90-days prior to the procedure, showing continuous AF\n3. Refractory or intolerant to at least one Class I-IV antiarrhythmic drug (AAD) as evidenced by recurrent symptomatic AF\n4. Age 18 years or older\n5. Able and willing to comply with all pre-, post-, and follow-up testing and requirements\n\nExclusion Criteria:\n\n1. Continuous AF \\> 12 months (longstanding persistent AF)\n2. Previous left atrial surgical or catheter ablation for atrial fibrillation or a previous procedure that required an incision in the left atrium with resulting scar\n3. Any cardiac procedure (surgical or percutaneous) within 90-days prior to the initial procedure\n4. CABG surgery within the 6-months (180-days) prior to the initial procedure\n5. Valvular cardiac surgical/percutaneous procedure (i.e. ventriculotomy, valve repair or replacement and/or presence of a prosthetic or mechanical valve)\n6. Any carotid stenting or endarterectomy\n7. Documented or known left atrial thrombus on imaging\n8. Left atrial diameter \\> 50 mm (parasternal long axis view or by CT)\n9. Left ventricular ejection fraction \\< 40%\n10. Unable to take anticoagulation medication due to contraindication or intolerance\n11. History of blood clotting or bleeding abnormalities\n12. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI) within the 3-months (90-days) prior to the initial procedure\n13. Documented thromboembolic event (including TIA) within the 12-months (365 days) prior to the initial procedure\n14. Rheumatic heart disease\n15. Uncontrolled heart failure or NYHA functional class III or IV\n16. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2)\n17. Awaiting cardiac transplantation or other cardiac surgery within the 12-months (365 days) following the initial ablation procedure\n18. Unstable angina at the time of the initial procedure\n19. Acute illness or active systemic infection or sepsis\n20. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, major surgical procedure in the preceding 3-months, or other reversible or non-cardiac cause\n21. Diagnosed atrial myxoma\n22. Presence of implanted implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)\n23. Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms\n24. Significant congenital anomaly or other anatomic or comorbid medical problem that in the opinion of the investigator would preclude enrollment in this study or compliance with the follow-up requirements or impact the scientific soundness of the clinical trial results\n25. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period\n26. Enrollment in an investigational study evaluating another device, biologic, or drug that may interfere with this clinical investigation at the time of the initial procedure or within 30 days prior to the initial procedure\n27. Presence of any condition that precludes appropriate vascular access or manipulation of catheter\n28. Life expectancy less than 12-months\n29. Body mass index \\> 40 kg/m2\n30. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication\n31. Renal failure requiring dialysis\n32. Vulnerable subject\n33. History of atriotomy or ventriotomy\n34. Implanted endocardial left atrial appendage occlusion device"}, 'identificationModule': {'nctId': 'NCT03650556', 'briefTitle': 'Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation (PERSIST-END IDE)', 'orgStudyIdInfo': {'id': 'ABT-CIP-10239'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ablation', 'description': 'Enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE).', 'interventionNames': ['Device: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™']}], 'interventions': [{'name': 'TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™', 'type': 'DEVICE', 'description': 'Ablation procedure for Persistent AF', 'armGroupLabels': ['Ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University Hospital (UAB)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'St. Bernards', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Heart Hosptial', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Health', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': 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York', 'country': 'United States', 'facility': 'New York University Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Cardiac Arrhythmia', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'The Heart Hospital Baylor Plano', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3050', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Royal Melbourne Hospital - City Campus', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}