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Single Chamber Atrial Leadless Pacing for Isolated Sinus Node Dysfunction

Recruitingn/aAges 18 Years - anyAllNorthwell Health
NCT07638995 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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
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What it tests

  • Implantable Loop Recorder
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Where

6 sites
South Shore University Hospital
Bay Shore, United States
Huntington Hospital
Huntington, United States
North Shore University Hospital
Manhasset, United States
Long Island Jewish Medical Center
New Hyde Park, United States
Lenox Hill Hospital
New York, United States
Staten Island University Hospital
Staten Island, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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