NCT07638995 · Northwell Health
Single Chamber Atrial Leadless Pacing for Isolated Sinus Node Dysfunction
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Bay Shore, New York
- Huntington, New York
- Manhasset, New York
- New Hyde Park, New York
- New York, New York
- Staten Island, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 10, 2026 · Source of record for eligibility and locations