Single Chamber Atrial Leadless Pacing for Isolated Sinus Node Dysfunction

NCT07638995 | Recruiting

• 1 other identifier: 25-0781
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Composite incidence of a newly prolonged PR interval

  24 months

• Need for system upgrade from a single chamber to dual chamber

  24 months

• Battery Longevity

  24 months

Interventions

Implantable Loop Recorder DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Atrioventricular block
• Bundle branch block
• History of atrial fibrillation
• Carotid sinus hypersensitivity
• Planned cardiac surgery
• Estimated life expectancy \< 1 year
• Presence of an existing ventricular pacemaker or implantable cardioverter defibrillator
• Known acute deep vein thrombosis of either lower extremity
• Unable to read or write
• Patient with Limited English Proficiency (LEP)
• Cognitively impaired individuals
• Pregnant

Sponsors & Collaborators

• Northwell Health: lead
• Abbott: collaborator

Study Sites (6)

South Shore University Hospital

Bay Shore, New York, 11706, United States

RECRUITING

Huntington Hospital

Huntington, New York, 11743, United States

RECRUITING

North Shore University Hospital

Manhasset, New York, 11030, United States

RECRUITING

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

RECRUITING

Lenox Hill Hospital

New York, New York, 10075, United States

RECRUITING

Staten Island University Hospital

Staten Island, New York, 10305, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James Gabriels, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salome Elia Reddy

CONTACT

516-881-7067; seliareddy@northwell.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): May 18, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

US (6)