Single Chamber Atrial Leadless Pacing for Isolated Sinus Node Dysfunction

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Implantable Loop Recorder

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Salome Elia Reddy; Phone Number: 516-881-7067; Email: seliareddy@northwell.edu

Study Locations

• United States
  • New York
    • Bay Shore, New York, United States, 11706
      • Recruiting
      • South Shore University Hospital
      • Contact: Rachel Gentles; Email: rgentles1@northwell.edu
      • Sub-Investigator: Jason Chinitz, MD
    • Huntington, New York, United States, 11743
      • Recruiting
      • Huntington Hospital
      • Contact: Jane Hubert; Email: jhubert@northwell.edu
      • Sub-Investigator: Paul Maccaro, MD
    • Manhasset, New York, United States, 11030
      • Recruiting
      • North Shore University Hospital
      • Principal Investigator: James Gabriels, MD
      • Contact: Salome Elia Reddy; Email: seliareddy@northwell.edu
      • Sub-Investigator: Laurence Epstein, MD
    • New Hyde Park, New York, United States, 11040
      • Recruiting
      • Long Island Jewish Medical Center
      • Sub-Investigator: Moussa Saleh, MD
      • Contact: Salome Elia Reddy; Email: seliareddy@northwell.edu
      • Sub-Investigator: Bruce Goldner, MD
    • New York, New York, United States, 10075
      • Recruiting
      • Lenox Hill Hospital
      • Sub-Investigator: Nicholas Skipitaris, MD
      • Contact: Kristie Coleman; Email: kcoleman1@northwell.edu
    • Staten Island, New York, United States, 10305
      • Recruiting
      • Staten Island University Hospital
      • Contact: Alexandra Pantea; Email: apantea@northwell.edu
      • Sub-Investigator: Marcin Kowalski, MD
      • Sub-Investigator: Valay Parikh, MD
      • Sub-Investigator: Samer Saouma, MD
      • Sub-Investigator: Rina Shah, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

1. 50 patients who receive an Aveir AR device as standard of care
2. Patients willing to receive an Assert-IQ loop recorder for research purposes
3. All sexes
4. Age > 18 years old
5. Able to provide written informed consent

Description

Inclusion Criteria:

1. Symptomatic sinus bradycardia
2. Sino-atrial exit block
3. Symptomatic sinus arrest with sinus pauses > 2 sec during waking hours
4. Symptomatic sinus bradycardia < 40 bpm for > 1 min during waking hours
5. PR interval ≤ 0.22 sec if aged < 70 years or PR interval ≤ 0.26 sec if aged ≥ 70 years
6. QRS width ≤ 0.12 sec
7. No prior PM implantation
8. Patients willing to receive an Assert-IQ loop recorder for research purposes

Exclusion Criteria:

1. Atrioventricular block
2. Bundle branch block
3. History of atrial fibrillation
4. Carotid sinus hypersensitivity
5. Planned cardiac surgery
6. Estimated life expectancy < 1 year
7. Presence of an existing ventricular pacemaker or implantable cardioverter defibrillator
8. Known acute deep vein thrombosis of either lower extremity
9. Unable to read or write
10. Patient with Limited English Proficiency (LEP)
11. Cognitively impaired individuals
12. Pregnant

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of atrial fibrillation	Incidence of atrial fibrillation in patients implanted with a single chamber (Aveir AR, Abbott) leadless pacemaker and a loop recorder.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite incidence of a newly prolonged PR interval	Composite incidence of a newly prolonged PR interval >/= 300ms or a need for system upgrade from a single chamber (Aveir AR, Abbott) leadless pacemaker to a dual chamber leadless pacemaker (Aveir DR, Abbott) at two-years	24 months
Need for system upgrade from a single chamber to dual chamber	Need for system upgrade from a single chamber (Aveir AR, Abbott) leadless pacemaker to a dual chamber leadless pacemaker (Aveir DR, Abbott) at two-years.	24 months
Battery Longevity	Remaining battery longevity of the single chamber leadless atrial pacemaker (Aveir, AR) compared with remaining battery longevity of subjects in the Aveir DR i2i study implanted with a dual chamber leadless pacemaker with comparable percentages of atrial pacing without ventricular pacing.	24 months

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: Abbott
• Investigators: Principal Investigator: James Gabriels, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2026
• Primary Completion (Estimated): May 18, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: 25-0781

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No