Determinates of Atrial Tracking and Prevalence of Atrial Fibrillation in the Micra AV2 (DANCE AFIB)

NCT ID: NCT07344961

Last Updated: 2026-02-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-29
• Study Completion Date: 2027-12-31

Brief Summary

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.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Micra AV2- Observational

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Participant or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements
• 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.
• Participants with a history of paroxysmal atrial fibrillation undergoing Micra AV2 implantation, as per standard of care.
• Age 18-85 years old with the ability to consent for the procedure
• Participant is consented within the enrollment window of the therapy received, as applicable
• English Speaking

Exclusion Criteria

• Participant who is, or is expected to be, inaccessible for follow-up
• Participation is excluded by local law
• Participant is currently enrolled or plans to enroll in concurrent drug/device study that may confound the study results
• Participant with persistent/chronic atrial fibrillation
• Prisoner or cognitively impaired due to the study procedures involving independent wearing of the holter monitor for research purposes.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haisam Ismail, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Salome Elia Reddy, PhD

Role: CONTACT

seliareddy@northwell.edu

516-600-1459

Emma Grace Lao

Role: CONTACT

elao1@northwell.edu

516-881-7037

Facility Contacts

Salome Elia Reddy, PhD

Role: primary

seliareddy@northwell.edu

516-600-1459

Emma Grace Lao

Role: backup

elao1@northwell.edu

516-881-7037

Other Identifiers

0696

Identifier Type: OTHER

Identifier Source: secondary_id

25-0696

Identifier Type: -

Identifier Source: org_study_id