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

NCT07344961 | Recruiting

• 2 other identifiers: 25-06960696
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• To evaluate the prevalence of atrial fibrillation in the Micra AV2 patients

  Through study completion, an average of 6 months

• To evaluate A4 amplitude trend changes during sinus rhythm and atrial fibrillation

  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.

  Through study completion, an average of 6 months

• To determine the ability of the Micra AV2 device to detect the presence and burden of atrial fibrillation

  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.

  Through study completion, an average of 6 months

Interventions

Micra AV2- Observational DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

AFIB patients

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Haisam Ismail, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salome Elia Reddy, PhD

CONTACT

516-600-1459; seliareddy@northwell.edu

Emma Grace Lao

CONTACT

516-881-7037; elao1@northwell.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 15, 2026
• Study Start: December 29, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)