NCT07638995Recruiting
Single Chamber Atrial Leadless Pacing for Isolated Sinus Node Dysfunction
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
The study aims to evaluate the following: 1) the incidence of new onset atrial fibrillation in patients with an atrial leadless pacemaker, 2) the need for upgrade from a standalone atrial leadless pacemaker to a dual chamber leadless pacemaker system, and 3) to compare the battery longevity of the Aveir AR at two years with the battery longevity of subjects implanted with dual chamber leadless pacemakers in the Aveir DR i2i study.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 5 Jun 2026
- Start date
- 18 May 2026
- Primary completion date
- 18 May 2029
- Lead sponsor
- Northwell Health
- Diseases
- Atrial fibrillation
- NCT number
- NCT07638995
What you commit to
- Study type: Observational
- Planned participants: 50
- From 18 May 2026 to the primary completion date, 18 May 2029
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of atrial fibrillation
- Carotid sinus hypersensitivity
- Planned cardiac surgery
- Known acute deep vein thrombosis of either lower extremity
Other
- Atrioventricular block
- Bundle branch block
- Estimated life expectancy \< 1 year
- Presence of an existing ventricular pacemaker or implantable cardioverter defibrillator
- Unable to read or write
- Patient with Limited English Proficiency (LEP)
- Cognitively impaired individuals
- Pregnant
Who the study is looking for
- Symptomatic sinus bradycardia
- Sino-atrial exit block
- Symptomatic sinus arrest with sinus pauses \> 2 sec during waking hours
- Symptomatic sinus bradycardia \< 40 bpm for \> 1 min during waking hours
- PR interval ≤ 0.22 sec if aged \< 70 years or PR interval ≤ 0.26 sec if aged ≥ 70 years
- QRS width ≤ 0.12 sec
- No prior PM implantation
- Patients willing to receive an Assert-IQ loop recorder for research purposes
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| South Shore University Hospital Coordinator of this site? Confirm its status | Bay Shore | United States | Recruiting |
| Huntington Hospital Coordinator of this site? Confirm its status | Huntington | United States | Recruiting |
| North Shore University Hospital Coordinator of this site? Confirm its status | Manhasset | United States | Recruiting |
| Long Island Jewish Medical Center Coordinator of this site? Confirm its status | New Hyde Park | United States | Recruiting |
| Lenox Hill Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Staten Island University Hospital Coordinator of this site? Confirm its status | Staten Island | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.