Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-26 @ 1:37 PM
Study NCT ID:
NCT05120193
Status:
COMPLETED
Last Update Posted:
2025-04-23
First Post:
2021-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'medtroniccrmtrials@medtronic.com', 'phone': '800-328-2518', 'title': 'Clinical Research Specialist', 'organization': 'Medtronic, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Sphere-9 Catheter', 'description': 'Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System\n\nMapping and Ablation: Minimally invasive catheter mapping and ablation procedure', 'otherNumAtRisk': 212, 'deathsNumAtRisk': 212, 'otherNumAffected': 0, 'seriousNumAtRisk': 212, 'deathsNumAffected': 2, 'seriousNumAffected': 36}, {'id': 'EG001', 'title': 'THERMOCOOL SMARTTOUCH SF', 'description': 'THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System\n\nMapping and Ablation: Minimally invasive catheter mapping and ablation procedure', 'otherNumAtRisk': 208, 'deathsNumAtRisk': 208, 'otherNumAffected': 0, 'seriousNumAtRisk': 208, 'deathsNumAffected': 3, 'seriousNumAffected': 41}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypochromic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Thyroid disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Retinal tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Mesenteric vascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oesophageal mucosa erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Systemic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Mouth Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vascular access site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Troponin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypervolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haemarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haemangioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Malignant neoplasm of ampulla of Vater', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Monoclonal gammopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Carotid artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vocal cord paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Prostatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Medical device implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypertensive urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Subjects With a Primary Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sphere-9 Catheter', 'description': 'Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System\n\nMapping and Ablation: Minimally invasive catheter mapping and ablation procedure'}, {'id': 'OG001', 'title': 'THERMOCOOL SMARTTOUCH SF', 'description': 'THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System\n\nMapping and Ablation: Minimally invasive catheter mapping and ablation procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.005', 'ciLowerLimit': '-0.028', 'ciUpperLimit': '0.037', 'groupDescription': 'The null hypothesis (H0) for the primary safety analysis is that the true rate of primary safety events for the investigational device (QI) is equal to or greater than the true rate for the control device (QC) plus a non-inferiority margin (NIM) of 0.08. The alternative hypothesis (HA) is that the rate of primary safety events for the investigational arm (QI) is less than the rate of primary safety events for the control arm (QC) plus the NIM of 0.08.\n\nH0: QI ≥ QC + 0.08 HA: QI \\< QC + 0.08', 'statisticalMethod': 'Farrington-Manning', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The primary safety analysis is performed at a one-sided Type I error rate of α = 0.05. The Farrington-Manning method is used to calculate the upper 95% confidence bound for the difference (QI - QC) between the rate of the primary safety endpoint in the investigational arm (QI) and the rate of the primary safety endpoint in the control arm (QC). If the upper confidence bound is less than 0.08, the study is considered to have demonstrated safety of the investigational device.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 Days', 'description': 'The primary safety endpoint is the incidence of the following device- or procedure-related serious adverse events (SAEs) following the index ablation procedure:\n\nWithin 7 days:\n\n* Death\n* Myocardial infarction\n* Phrenic nerve paralysis\n* Transient ischemic attack (TIA)\n* Stroke/cerebrovascular accident (CVA)\n* Thromboembolism\n* Major vascular access complications / bleeding\n* Heart block\n* Gastroparesis\n* Severe pericarditis\n* Hospitalization due to cardiovascular or pulmonary AE\n\nWithin 30 days:\n\n• Cardiac tamponade / perforation\n\nWithin 90 days:\n\n• Atrio-esophageal fistula\n\nWithin 180 days:\n\n• Pulmonary vein stenosis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who provided informed consent, were randomized and underwent insertion of the assigned study device (experimental or active comparator), defined as the device emerging from the sheath into the bloodstream.'}, {'type': 'PRIMARY', 'title': 'Percent of Subjects Free From Primary Effectiveness Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sphere-9 Catheter', 'description': 'Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System\n\nMapping and Ablation: Minimally invasive catheter mapping and ablation procedure'}, {'id': 'OG001', 'title': 'THERMOCOOL SMARTTOUCH SF', 'description': 'THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System\n\nMapping and Ablation: Minimally invasive catheter mapping and ablation procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.009', 'ciUpperLimit': '0.168', 'groupDescription': 'The null hypothesis (H0) is that the true rate of primary effectiveness endpoint success (no failures through Day 360) for the investigational device (PI) is less than or equal to the true rate for the control device (PC) minus the NIM of 0.15. The alternative hypothesis (HA) is that the success rate for the investigational arm (PI) is greater than the success rate for the control device (PC) minus the NIM of 0.15.\n\nH0: PI ≤ PC - 0.15 HA: PI \\> PC - 0.15', 'statisticalMethod': 'Farrington-Manning', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The primary effectiveness analysis (PSE) is performed at a one-sided Type I error rate of α = 0.025. The Farrington-Manning method is used to calculate the lower 97.5% confidence bound for the difference (PI - PC) between the rate of the PSE in the investigational arm (PI) and the rate of the PSE in the control arm (PC). If the lower confidence bound is greater than -0.15, the study is considered to have demonstrated effectiveness of the investigational device.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'The primary effectiveness endpoint is freedom from documented recurrence of AF, atrial tachycardia (AT), or atrial flutter (AFL) based on electrocardiographic data through 12-month follow-up and excluding a 90-day blanking period. The following are considered primary effectiveness endpoint failures:\n\n* Inability to isolate all targeted pulmonary veins during the index procedure.\n* Ablation using devices other than the assigned study device for any left atrial ablation during the index procedure.\n* Any repeat ablation, surgical ablation, or arrhythmia surgery for treatment of recurrent AF/AT/AFL after the index procedure.\n* Documented AF/AT/AFL recurrence after the 90-day blanking period.\n* Class I or III AAD dose increase from the historic maximum ineffective dose (prior to the index procedure) or initiation of a new Class I or III AAD for treatment of AF/AT/AFL after the 90-day blanking period.\n* DC cardioversion for AF/AT/AFL after the 90-day blanking period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who provided informed consent, were randomized and underwent insertion of the assigned study device (experimental or active comparator), defined as the device emerging from the sheath into the bloodstream.'}, {'type': 'SECONDARY', 'title': 'Energy Application Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sphere-9 Catheter', 'description': 'Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System\n\nMapping and Ablation: Minimally invasive catheter mapping and ablation procedure'}, {'id': 'OG001', 'title': 'THERMOCOOL SMARTTOUCH SF', 'description': 'THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System\n\nMapping and Ablation: Minimally invasive catheter mapping and ablation procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '36.4', 'spread': '17.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-29.2', 'ciLowerLimit': '-31.7', 'ciUpperLimit': '-26.8', 'groupDescription': 'The null hypothesis (H0) is that the mean total energy application time during the ablation procedure for the investigational device (ETI) is greater than or equal to the mean time for the control device (ETC). The alternative hypothesis (HA) is that the mean total energy application time for the investigational device is less.\n\nH0: ETI ≥ ETC versus HA: ETI \\< ETC', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'Total energy application time during the index ablation procedure', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who provided informed consent, were randomized and underwent insertion of the assigned study device (experimental or active comparator), defined as the device emerging from the sheath into the bloodstream.'}, {'type': 'SECONDARY', 'title': 'Treatment Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sphere-9 Catheter', 'description': 'Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System\n\nMapping and Ablation: Minimally invasive catheter mapping and ablation procedure'}, {'id': 'OG001', 'title': 'THERMOCOOL SMARTTOUCH SF', 'description': 'THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System\n\nMapping and Ablation: Minimally invasive catheter mapping and ablation procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '46.7', 'spread': '20.0', 'groupId': 'OG000'}, {'value': '73.5', 'spread': '34.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.8', 'ciLowerLimit': '-32.2', 'ciUpperLimit': '-21.4', 'groupDescription': 'The null hypothesis (H0) is that the mean treatment time for the investigational device (TTI) is greater than or equal to the mean treatment time for the control device (TTC). The alternative hypothesis (HA) is that the mean treatment time for the investigational device is less.\n\nH0: TTI ≥ TTC versus HA: TTI \\< TTC', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'Time from start to end of energy delivery', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who provided informed consent, were randomized and underwent insertion of the assigned study device (experimental or active comparator), defined as the device emerging from the sheath into the bloodstream.'}, {'type': 'SECONDARY', 'title': 'Procedure Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sphere-9 Catheter', 'description': 'Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System\n\nMapping and Ablation: Minimally invasive catheter mapping and ablation procedure'}, {'id': 'OG001', 'title': 'THERMOCOOL SMARTTOUCH SF', 'description': 'THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System\n\nMapping and Ablation: Minimally invasive catheter mapping and ablation procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '100.9', 'spread': '30.8', 'groupId': 'OG000'}, {'value': '126.1', 'spread': '49.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.1', 'ciLowerLimit': '-33.0', 'ciUpperLimit': '-17.3', 'groupDescription': 'The null hypothesis (H0) is that the mean procedure time for the investigational device (PTI) is greater than or equal to the mean procedure time for the control device (PTC). The alternative hypothesis (HA) is that the mean procedure time for the investigational device is less.\n\nH0: PTI ≥ PTC versus HA: PTI \\< PTC', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'Time from start to end of venous access', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who provided informed consent, were randomized and underwent insertion of the assigned study device (experimental or active comparator), defined as the device emerging from the sheath into the bloodstream.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sphere-9 Catheter', 'description': 'Sphere-9™ Catheter; Affera Mapping System; Affera Ablation System\n\nMapping and Ablation: Minimally invasive catheter mapping and ablation procedure'}, {'id': 'FG001', 'title': 'THERMOCOOL SMARTTOUCH SF', 'description': 'THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System\n\nMapping and Ablation: Minimally invasive catheter mapping and ablation procedure'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '212'}, {'groupId': 'FG001', 'numSubjects': '208'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '209'}, {'groupId': 'FG001', 'numSubjects': '199'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'preAssignmentDetails': 'There were 37 Roll-In subjects, 8 subjects that exited the study prior to randomization, and 12 randomized subjects that exited the study prior to the index ablation procedure.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '420', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sphere-9 Catheter', 'description': 'Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System\n\nMapping and Ablation: Minimally invasive catheter mapping and ablation procedure'}, {'id': 'BG001', 'title': 'THERMOCOOL SMARTTOUCH SF', 'description': 'THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System\n\nMapping and Ablation: Minimally invasive catheter mapping and ablation procedure'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.8', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '66.7', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '67.3', 'spread': '8.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '407', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '398', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '356', 'groupId': 'BG002'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Subjects who provided informed consent, were randomized and underwent insertion of the assigned study device (experimental or active comparator), defined as the device emerging from the sheath into the bloodstream.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-03', 'size': 5127324, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-01-09T15:05', 'hasProtocol': True}, {'date': '2022-06-03', 'size': 1083278, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-01-09T15:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Subjects will be blinded to treatment assignment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 477}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2021-10-25', 'resultsFirstSubmitDate': '2025-01-09', 'studyFirstSubmitQcDate': '2021-11-02', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-09', 'studyFirstPostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Subjects With a Primary Adverse Event', 'timeFrame': '180 Days', 'description': 'The primary safety endpoint is the incidence of the following device- or procedure-related serious adverse events (SAEs) following the index ablation procedure:\n\nWithin 7 days:\n\n* Death\n* Myocardial infarction\n* Phrenic nerve paralysis\n* Transient ischemic attack (TIA)\n* Stroke/cerebrovascular accident (CVA)\n* Thromboembolism\n* Major vascular access complications / bleeding\n* Heart block\n* Gastroparesis\n* Severe pericarditis\n* Hospitalization due to cardiovascular or pulmonary AE\n\nWithin 30 days:\n\n• Cardiac tamponade / perforation\n\nWithin 90 days:\n\n• Atrio-esophageal fistula\n\nWithin 180 days:\n\n• Pulmonary vein stenosis'}, {'measure': 'Percent of Subjects Free From Primary Effectiveness Failure', 'timeFrame': '12 months', 'description': 'The primary effectiveness endpoint is freedom from documented recurrence of AF, atrial tachycardia (AT), or atrial flutter (AFL) based on electrocardiographic data through 12-month follow-up and excluding a 90-day blanking period. The following are considered primary effectiveness endpoint failures:\n\n* Inability to isolate all targeted pulmonary veins during the index procedure.\n* Ablation using devices other than the assigned study device for any left atrial ablation during the index procedure.\n* Any repeat ablation, surgical ablation, or arrhythmia surgery for treatment of recurrent AF/AT/AFL after the index procedure.\n* Documented AF/AT/AFL recurrence after the 90-day blanking period.\n* Class I or III AAD dose increase from the historic maximum ineffective dose (prior to the index procedure) or initiation of a new Class I or III AAD for treatment of AF/AT/AFL after the 90-day blanking period.\n* DC cardioversion for AF/AT/AFL after the 90-day blanking period.'}], 'secondaryOutcomes': [{'measure': 'Energy Application Time', 'timeFrame': 'Day 0', 'description': 'Total energy application time during the index ablation procedure'}, {'measure': 'Treatment Time', 'timeFrame': 'Day 0', 'description': 'Time from start to end of energy delivery'}, {'measure': 'Procedure Time', 'timeFrame': 'Day 0', 'description': 'Time from start to end of venous access'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['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': '39922404', 'type': 'DERIVED', 'citation': 'Kiehl EL, Mountantonakis SE, Mansour MC, Nair DG, Sharma D, Taigen TL, Neuzil P, Kautzner J, Osorio J, Natale A, Hummel JD, Amin AK, Siddiqui UR, Bulava A, Doshi SK, Patel CP, Greenberg YJ, Tung RH, Harlev D, Hultz P, Rosen S, van Bragt KA, Tarakji KG, Reddy VY, Anter E; SPHERE Per-AF Investigators. Operator learning curve with a novel dual-energy lattice-tip ablation system. Heart Rhythm. 2025 Feb 6:S1547-5271(25)00120-1. doi: 10.1016/j.hrthm.2025.02.006. Online ahead of print.'}, {'pmid': '38760584', 'type': 'DERIVED', 'citation': 'Anter E, Mansour M, Nair DG, Sharma D, Taigen TL, Neuzil P, Kiehl EL, Kautzner J, Osorio J, Mountantonakis S, Natale A, Hummel JD, Amin AK, Siddiqui UR, Harlev D, Hultz P, Liu S, Onal B, Tarakji KG, Reddy VY; SPHERE PER-AF Investigators. Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial. Nat Med. 2024 Aug;30(8):2303-2310. doi: 10.1038/s41591-024-03022-6. Epub 2024 May 17.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter, randomized clinical evaluation of the Sphere-9 Mapping and Ablation Catheter with the Affera Mapping and Ablation System. Subjects will be randomly assigned 1:1 to receive treatment with either the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System (investigational device) or the THERMOCOOL SMARTTOUCH® SF radiofrequency ablation catheter (control device).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Symptomatic PerAF documented by (1) a physician's note indicating symptoms consistent with AF sustained longer than 7 days but less than 12 months; AND either (2a) a 24-hour Holter documenting continuous AF within the past year OR (2b) two electrocardiograms (from any form of rhythm monitoring, including consumer devices) taken at least 7 days apart within the past year, each showing continuous AF.\n2. Failure or intolerance of at least one Class I or III anti-arrhythmic drug (AAD).\n3. Suitable candidate for catheter ablation.\n4. Adults aged 18 - 80 years.\n5. Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.\n6. Willing and able to provide informed consent.\n\nExclusion Criteria:\n\n1. Continuous AF lasting for 12 months or longer.\n2. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or other reversible or non-cardiac cause.\n3. Previous left atrial ablation or surgical procedure (including septal closure or left atrial appendage closure).\n4. Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).\n5. Any carotid stenting or endarterectomy.\n6. Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within the 90 days prior to the initial procedure.\n7. Coronary artery bypass graft (CABG) procedure within the 6 months prior to the initial procedure.\n8. Awaiting cardiac transplantation or other cardiac surgery within the 12 months following the initial ablation procedure.\n9. Presence of a permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function).\n10. Documented thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the initial ablation procedure.\n11. Documented left atrial thrombus on imaging.\n12. History of blood clotting or bleeding abnormalities.\n13. Any condition contraindicating chronic anticoagulation.\n14. Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure.\n15. Body mass index \\>40 kg/m2.\n16. Left atrial diameter \\>55 mm (anterioposterior).\n17. Diagnosed atrial myxoma.\n18. Left ventricular ejection fraction (EF) \\< 35%.\n19. Uncontrolled heart failure or NYHA Class III or IV heart failure.\n20. Rheumatic heart disease.\n21. Hypertrophic cardiomyopathy.\n22. Unstable angina.\n23. Moderate to severe mitral valve stenosis.\n24. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).\n25. Primary pulmonary hypertension.\n26. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.\n27. Renal failure requiring dialysis.\n28. History of severe Gastroesophageal Reflux Disease (GERD) requiring surgical and/or mechanical intervention.\n29. Acute illness, active systemic infection, or sepsis.\n30. Contraindication to both computed tomography and magnetic resonance angiography.\n31. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical study results.\n32. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence.\n33. Current or anticipated participation in any other clinical study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor.\n34. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.\n35. Known drug or alcohol dependency.\n36. Life expectancy less than 12 months.\n37. Vulnerable subject (such as a prisoner or handicapped or mentally disabled person)."}, 'identificationModule': {'nctId': 'NCT05120193', 'acronym': 'SPHERE Per-AF', 'briefTitle': 'Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Ablation Solutions'}, 'officialTitle': 'Treatment of Persistent Atrial Fibrillation With the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System', 'orgStudyIdInfo': {'id': 'CP-00009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sphere-9 Catheter', 'description': 'Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System', 'interventionNames': ['Device: Mapping and Ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'THERMOCOOL SMARTTOUCH SF', 'description': 'THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System', 'interventionNames': ['Device: Mapping and Ablation']}], 'interventions': [{'name': 'Mapping and Ablation', 'type': 'DEVICE', 'description': 'Minimally invasive catheter mapping and ablation procedure', 'armGroupLabels': ['Sphere-9 Catheter', 'THERMOCOOL SMARTTOUCH SF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35243', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Arrhythmia Institute at Grandview', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arrhythmia Research Group', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Heart Institute', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Naples Heart Institute', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '11219', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Maimonides Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The OhioHealth Research Institute', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '18901', 'city': 'Doylestown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Doylestown Hospital', 'geoPoint': {'lat': 40.31011, 'lon': -75.12989}}, {'zip': '17043', 'city': 'Wormleysburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center Pinnacle Health', 'geoPoint': {'lat': 40.26287, 'lon': -76.91386}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Cardiac Arrhythmia Research Foundation', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Norfolk General Hospital', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '370 01', 'city': 'České Budějovice', 'country': 'Czechia', 'facility': 'Nemocnice Ceske Budejovice', 'geoPoint': {'lat': 48.97447, 'lon': 14.47434}}, {'zip': '140 21', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Institut Klinicke a Experimentani Mediciny', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '150 30', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Nemocnice Na Homolce', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '6093000', 'city': 'Zrifin', 'country': 'Israel', 'facility': 'Shamir Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Ablation Solutions', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}