Atrial FibrillationNCT07638995
Single Chamber Atrial Leadless Pacing for Isolated Sinus Node Dysfunction
An observational study of Atrial Fibrillation, run by Northwell Health at 6 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Implantable Loop Recorder
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 May 2026to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. 50 patients who receive an Aveir AR device as standard of care 2. Patients willing to receive an Assert-IQ loop recorder for research purposes 3. All sexes 4. Age > 18 years old 5. Able to provide written informed consent
Who may be able to join
- 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
Who cannot join
- Atrioventricular block
- Bundle branch block
- History of atrial fibrillation
- Carotid sinus hypersensitivity
- Planned cardiac surgery
- Estimated life expectancy < 1 year
Show all 12Show fewer
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
South Shore University Hospital
Bay Shore, New York, 11706
Rachel Gentles, rgentles1@northwell.edu
Jason Chinitz, MD
- Recruiting
Huntington Hospital
Huntington, New York, 11743
Jane Hubert, jhubert@northwell.edu
Paul Maccaro, MD
- Recruiting
North Shore University Hospital
Manhasset, New York, 11030
Salome Elia Reddy, seliareddy@northwell.edu
James Gabriels, MD
- Recruiting
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Salome Elia Reddy, seliareddy@northwell.edu
Bruce Goldner, MD
- Recruiting
Lenox Hill Hospital
New York, New York, 10075
Kristie Coleman, kcoleman1@northwell.edu
Nicholas Skipitaris, MD
- Recruiting
Staten Island University Hospital
Staten Island, New York, 10305
Alexandra Pantea, apantea@northwell.edu
Marcin Kowalski, MD
About this study
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Implantable Loop Recorder
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Loop RecorderDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of atrial fibrillation
Incidence of atrial fibrillation in patients implanted with a single chamber (Aveir AR, Abbott) leadless pacemaker and a loop recorder.
Measured: 24 months
Secondary outcomes (3)
Composite incidence of a newly prolonged PR interval
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
Measured: 24 months
Need for system upgrade from a single chamber to dual chamber
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.
Measured: 24 months
Battery Longevity
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start18 May 2026
- Primary completion18 May 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- James Gabriels, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638995
- Sponsor's protocol ID
- 25-0781
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Chamber Atrial Leadless Pacing for Isolated Sinus Node Dysfunction
- ClinicalTrials.gov ID
- NCT07638995
- Acronym / sponsor ID
- 25-0781
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 18 May 2026 (actual)
- Primary completion
- 18 May 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. 50 patients who receive an Aveir AR device as standard of care 2. Patients willing to receive an Assert-IQ loop recorder for research purposes 3. All sexes 4. Age > 18 years old 5. Able to provide written informed consent
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- Atrioventricular block
- Bundle branch block
- History of atrial fibrillation
- Carotid sinus hypersensitivity
- Planned cardiac surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable Loop RecorderImplantation 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. | Device | – |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Gabriels, MD principal investigator
Northwell Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Northwell Health at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salome Elia Reddy (516-881-7067, seliareddy@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of atrial fibrillation (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.