Recruiting

Aveir AR

Sponsor:

Northwell Health

Code:

NCT07638995

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Implantable Loop Recorder

Study Details

Brief 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

Atrial Fibrillation

Study ID

NCT07638995

Start date

May 18, 2026

Status verified date

Jun, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

May 18, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Incidence of atrial fibrillation [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Salome Elia Reddy

516-881-7067seliareddy@northwell.edu

Locations

South Shore University Hospital

Recruiting

Bay Shore, New York, United States, 11706

Contacts

Rachel Gentles

rgentles1@northwell.edu

Huntington Hospital

Recruiting

Huntington, New York, United States, 11743

Contacts

Jane Hubert

jhubert@northwell.edu

North Shore University Hospital

Recruiting

Manhasset, New York, United States, 11030

Contacts

Salome Elia Reddy

seliareddy@northwell.edu

Principal Investigator:

James Gabriels, MD

Long Island Jewish Medical Center

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Salome Elia Reddy

seliareddy@northwell.edu

Lenox Hill Hospital

Recruiting

New York, New York, United States, 10075

Contacts

Kristie Coleman

kcoleman1@northwell.edu

Staten Island University Hospital

Recruiting

Staten Island, New York, United States, 10305

Contacts

Alexandra Pantea

apantea@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Jun 10, 2026

Last verified

Jun, 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 2026-06-10.