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NCT Number: NCT07638995

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

South Shore University Hospital, Bay Shore, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of atrial fibrillation

    Time frame: 24 months

    Incidence of atrial fibrillation in patients implanted with a single chamber (Aveir AR, Abbott) leadless pacemaker and a loop recorder.

Secondary outcomes

  1. Composite incidence of a newly prolonged PR interval

    Time frame: 24 months

    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

  2. Need for system upgrade from a single chamber to dual chamber

    Time frame: 24 months

    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.

  3. Battery Longevity

    Time frame: 24 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Salome Elia Reddy

CONTACT

[email protected]

516-881-7067

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Abbott

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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