Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:49 AM
Study NCT ID:
NCT07344961
Status:
RECRUITING
Last Update Posted:
2026-02-04
First Post:
2025-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determinates of Atrial Tracking and Prevalence of Atrial Fibrillation in the Micra AV2 (DANCE AFIB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 50}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-02', 'studyFirstSubmitDate': '2025-12-10', 'studyFirstSubmitQcDate': '2026-01-07', 'lastUpdatePostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the prevalence of atrial fibrillation in the Micra AV2 patients', 'timeFrame': 'Through study completion, an average of 6 months'}, {'measure': 'To evaluate A4 amplitude trend changes during sinus rhythm and atrial fibrillation', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'To evaluate the presence of paroxysmal atrial fibrillation and the degree to which atrial activity and A4 amplitude trend changes will be assessed using a designated Medtronic Research Holter monitor that detects Micra AV2 signals at any point in the study during episodes of sinus rhythm and atrial fibrillation.'}, {'measure': 'To determine the ability of the Micra AV2 device to detect the presence and burden of atrial fibrillation', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Micra AV2 placement indications will be at the discretion of the treating electrophysiologist, but are expected to be predominantly atrioventricular block. Periodic device interrogations will be reviewed for the presence of effective atrial tracking during sinus rhythm.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Paroxysmal Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This is a prospective, descriptive study. Safety endpoints will not be assessed. All eligible patients that have a history of paroxysmal atrial fibrillation and an indication to undergo Micra AV2 device placement as per standard of care (SOC) across the participating sites within the Northwell Health System can be included in this analysis. Micra AV2 placement indications will be at the discretion of the treating electrophysiologist, but are expected to be predominantly atrioventricular block. Periodic device interrogations will be reviewed for the presence of effective atrial tracking during sinus rhythm . The presence of paroxysmal atrial fibrillation and the degree to which atrial activity and A4 amplitude trend changes will be assessed using a designated Medtronic Research Holter monitor that detects Micra AV2 signals at any point in the study during a episodes of sinus rhythm and atrial fibrillation. Patients who have atrial fibrillation during index hospitalization will undergo placement of the Medtronic Holter monitor as part of the standard of care index hospitalization. Eligible outpatients will undergo placement of the Medtronic Research Holter Monitor in the office.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'AFIB patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements\n* Participant has been implanted with the Micra AV2 device or is intended to receive or be treated with an eligible Micra AV2 device as per standard of care.\n* Participants with a history of paroxysmal atrial fibrillation undergoing Micra AV2 implantation, as per standard of care.\n* Age 18-85 years old with the ability to consent for the procedure\n* Participant is consented within the enrollment window of the therapy received, as applicable\n* English Speaking\n\nExclusion Criteria:\n\n* Participant who is, or is expected to be, inaccessible for follow-up\n* Participation is excluded by local law\n* Participant is currently enrolled or plans to enroll in concurrent drug/device study that may confound the study results\n* Participant with persistent/chronic atrial fibrillation\n* Prisoner or cognitively impaired due to the study procedures involving independent wearing of the holter monitor for research purposes.'}, 'identificationModule': {'nctId': 'NCT07344961', 'acronym': 'DANCE AFIB', 'briefTitle': 'Determinates of Atrial Tracking and Prevalence of Atrial Fibrillation in the Micra AV2 (DANCE AFIB)', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Determinates of Atrial Tracking and Prevalence of Atrial Fibrillation in the Micra AV2 (DANCE AFIB)', 'orgStudyIdInfo': {'id': '25-0696'}, 'secondaryIdInfos': [{'id': '0696', 'type': 'OTHER', 'domain': 'Northwell'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Micra AV2- Observational', 'type': 'DEVICE', 'description': 'All eligible patients that have a history of paroxysmal atrial fibrillation and an indication to undergo Micra AV2 device placement as per standard of care (SOC) across the participating sites within the Northwell Health System can be included in this analysis. Micra AV2 placement indications will be at the discretion of the treating electrophysiologist, but are expected to be predominantly atrioventricular block.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Salome Elia Reddy, PhD', 'role': 'CONTACT', 'email': 'seliareddy@northwell.edu', 'phone': '516-600-1459'}, {'name': 'Emma Grace Lao', 'role': 'CONTACT', 'email': 'elao1@northwell.edu', 'phone': '516-881-7037'}], 'facility': 'Long Island Jewish Medical Center', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}], 'centralContacts': [{'name': 'Salome Elia Reddy, PhD', 'role': 'CONTACT', 'email': 'seliareddy@northwell.edu', 'phone': '516-600-1459'}, {'name': 'Emma Grace Lao', 'role': 'CONTACT', 'email': 'elao1@northwell.edu', 'phone': '516-881-7037'}], 'overallOfficials': [{'name': 'Haisam Ismail, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwell Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}