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Recruiting NCT07638995

Single Chamber Atrial Leadless Pacing for Isolated Sinus Node Dysfunction

— Observational Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Implantable Loop Recorder.
Who it may be relevant to
Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Primary outcome measures

  • Incidence of atrial fibrillation [Time frame: 24 months]
Secondary outcome measures (3)
  • Composite incidence of a newly prolonged PR interval [Time frame: 24 months]
  • Need for system upgrade from a single chamber to dual chamber [Time frame: 24 months]
  • Battery Longevity [Time frame: 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 6 centers
  • South Shore University Hospital — Bay Shore
  • Huntington Hospital — Huntington
  • North Shore University Hospital — Manhasset
  • Long Island Jewish Medical Center — New Hyde Park
  • Lenox Hill Hospital — New York
  • Staten Island University Hospital — Staten Island

Identifiers

NCT: NCT07638995 · 25-0781

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗