Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-31 @ 1:18 PM
Study NCT ID:
NCT06858306
Status:
RECRUITING
Last Update Posted:
2025-11-03
First Post:
2025-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SPHERE Per-AF Post-Approval Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2030-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-31', 'studyFirstSubmitDate': '2025-02-26', 'studyFirstSubmitQcDate': '2025-03-03', 'lastUpdatePostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety Objective', 'timeFrame': 'Through 180 days Post-Procedure', 'description': 'Estimate the primary safety adverse event (AE) rate for ablation using the Sphere-9™ Catheter and Affera™ Ablation System.'}, {'measure': 'Primary Effectiveness Objective', 'timeFrame': 'Through 36 months Post-Procedure', 'description': 'Estimate the 36-month freedom from atrial fibrillation (AF), atrial tachycardia (AT) or atrial flutter (AFL) recurrence following ablation procedure using the Sphere-9™ Catheter and Affera™ Ablation System.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Persistent Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'SPHERE Per-AF Post-Approval Study is a prospective, multi-center, non-randomized, observational trial. Subjects will be treated with the Sphere-9™ Catheter and Affera™ Ablation System and followed through 36 months.', 'detailedDescription': 'The purpose of the study is to evaluate the long-term effectiveness and safety of the Sphere-9™ Catheter and Affera™ Ablation System in a post-approval setting for the treatment of drug refractory, recurrent, symptomatic, persistent AF (episode duration less than one year).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects 18 years or older with a planned de novo procedure using commercially available Sphere-9™ Catheter and Affera™ Ablation System.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A diagnosis of recurrent symptomatic persistent AF (continuous AF sustained longer than 7 days but less than 12 months)\n2. Refractory (i.e. not effective, not tolerated, or not desired) to at least one Class I or III antiarrhythmic drug (AAD)\n3. Patient is ≥ 18 years of age\n4. Planned de novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera Ablation System\n5. Patient is willing and able to comply with study requirements and give informed consent\n\nExclusion Criteria:\n\n1. Long-standing persistent AF (continuous AF sustained \\>12 months)\n2. Prior left atrial catheter or surgical ablation\n3. Life expectancy \\<36 months\n4. Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)\n5. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic'}, 'identificationModule': {'nctId': 'NCT06858306', 'briefTitle': 'SPHERE Per-AF Post-Approval Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Ablation Solutions'}, 'officialTitle': 'SPHERE Per-AF Post-Approval Study, an Addendum to the Affera Global Registry', 'orgStudyIdInfo': {'id': 'SPHERE Per-AF PAS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Persistent Atrial Fibrillation', 'interventionNames': ['Device: Sphere-9™ Catheter and Affera™ Ablation System']}], 'interventions': [{'name': 'Sphere-9™ Catheter and Affera™ Ablation System', 'type': 'DEVICE', 'description': 'De novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera™ Ablation System', 'armGroupLabels': ['Persistent Atrial Fibrillation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brooke Stanga, Research Coordinator', 'role': 'CONTACT', 'email': 'stanga.brooke@mayo.edu', 'phone': '507-422-6692'}, {'name': 'Chritopher DeSimone, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10467', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jose Matias, Research Coordinator', 'role': 'CONTACT', 'email': 'jmatias@montefiore.org', 'phone': '649-599-1506'}, {'name': 'Luigi Di Biase, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '18901', 'city': 'Doylestown', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shannon McDonald, Research Coordinator', 'role': 'CONTACT', 'email': 'shannon.mcdonald2@pennmedicine.upenn.edu', 'phone': '215-345-2227'}, {'name': 'Robert Sangrigoli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Doylestown Health Cardiology', 'geoPoint': {'lat': 40.31011, 'lon': -75.12989}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Olivia Moore, Research Coordinator', 'role': 'CONTACT', 'email': 'olivia.moore@ahn.org', 'phone': '(412) 359-5295'}, {'name': 'Amit Thosani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tara Craig, Research Coordinator', 'role': 'CONTACT', 'email': 'taracraig@texashealth.org', 'phone': '(817) 250-4960'}, {'name': 'Theodore Takata, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Texas Health Resources', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chinwe Ngumezi, Research Coordinator', 'role': 'CONTACT', 'email': 'ccngumezi@houstonmethodist.org', 'phone': '(713) 441-6548'}, {'name': 'Miguel Valderrabano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cathy Roy, Research Coordinator', 'role': 'CONTACT', 'email': 'cjp6t@uvahealth.org', 'phone': '(434) 982-6401'}, {'name': 'Mike Mangrum, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Virginia Medical Center', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '24501', 'city': 'Lynchburg', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michelle Carter, Research Coordinator', 'role': 'CONTACT', 'email': 'michelle.carter@centrahealth.com', 'phone': '434-200-5252'}, {'name': 'Chinmaya Mareddy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centra Medical Group Stroobants Cardiovascular Center', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}], 'centralContacts': [{'name': 'Libby Bergmann', 'role': 'CONTACT', 'email': 'libby.bergmann@medtronic.com', 'phone': 'libby.bergmann@medtronic.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Ablation Solutions', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}