One-chamber leadless atrial pacing and loop recorder follow-up in sinus node dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will enroll patients with symptomatic sinus bradycardia who have no prior pacemaker and will receive an Assert-IQ loop recorder to track heart activity. It aims to measure how often new atrial fibrillation develops, how often a single-chamber leadless system needs upgrading to dual-chamber, and how long the Aveir AR battery lasts compared with similar devices in a previous study. Data will come from implanted devices and loop recorder readings over time. The study is sponsored by Northwell Health with Abbott as a collaborator, across multiple New York hospitals.

Why it matters

Who can join: the full rules

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

Where it's running

• South Shore University Hospital
  Bay Shore, New York, United States Recruiting
• Huntington Hospital
  Huntington, New York, United States Recruiting
• North Shore University Hospital
  Manhasset, New York, United States Recruiting
• Long Island Jewish Medical Center
  New Hyde Park, New York, United States Recruiting
• Lenox Hill Hospital
  New York, New York, United States Recruiting
• Staten Island University Hospital
  Staten Island, New York, United States Recruiting

Study contacts

• Principal investigator: James Gabriels, MD — Northwell Health
• Study coordinator: Salome Elia Reddy
• Email: seliareddy@northwell.edu
• Phone: 516-881-7067

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.