Recruiting

Micra AV2

Sponsor:

Northwell Health

Code:

NCT07344961

Conditions

Paroxysmal Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Micra AV2- Observational

Study Details

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 ID

NCT07344961

Start date

Dec 29, 2025

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

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.

Primary outcome measure

  • To evaluate the prevalence of atrial fibrillation in the Micra AV2 patients [ Time Frame: Through study completion, an average of 6 months ]
  • To evaluate A4 amplitude trend changes during sinus rhythm and atrial fibrillation [ Time Frame: 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 [ Time Frame: Through study completion, an average of 6 months ]

Central Contacts and Locations

Central contacts

Locations

Long Island Jewish Medical Center

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

More Information

Sponsor

Northwell Health

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-02-04.