Determinates of Atrial Tracking and Prevalence of Atrial Fibrillation in the Micra AV2 (DA
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 incl
| Condition(s) | Paroxysmal Atrial Fibrillation |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 monit |
| Who can participate | 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 plan |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Northwell Health |
| Locations | New Hyde Park, New York, United States |
| Start date | 2025-12-29 |
| NCT ID | NCT07344961 |
| Official listing | https://clinicaltrials.gov/study/NCT07344961 |