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Single Chamber Atrial Leadless Pacing for Isolated Sinus Node Dysfunction

NCT07638995 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-06-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Implantable Loop Recorder

Implantation of a loop recorder in subjects with sick sinus syndrome and normal atrioventricular conduction who are receiving an atrial leadless pacemaker as standard of care.

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Northwell Health

    lead OTHER

Principal Investigators

  • James Gabriels, MD · Northwell Health

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-18
Primary Completion
2029-05-18
Completion
2029-12-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07638995 on ClinicalTrials.gov