Single Chamber Atrial Leadless Pacing for Isolated Sinus Node Dysfunction

Part of paid clinical trials in Bay Shore, New York.

Sponsor
Northwell Health
Study ID
NCT07638995
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Implantable Loop Recorder — DEVICE
    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.

Study Details

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.

Key Dates

Start date
May 18, 2026
Status verified
Jun 2026
Primary completion
May 18, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
50 participants (estimated)

Primary Outcome Measure

Incidence of atrial fibrillation [ Time Frame: 24 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
South Shore University HospitalBay ShoreNew York11706
Rachel Gentles
[email protected]
Jason Chinitz, MD (SUB_INVESTIGATOR)
Huntington HospitalHuntingtonNew York11743
Paul Maccaro, MD (SUB_INVESTIGATOR)
North Shore University HospitalManhassetNew York11030
Salome Elia Reddy
[email protected]
James Gabriels, MD (PRINCIPAL_INVESTIGATOR)
Laurence Epstein, MD (SUB_INVESTIGATOR)
Long Island Jewish Medical CenterNew Hyde ParkNew York11040
Salome Elia Reddy
[email protected]
Bruce Goldner, MD (SUB_INVESTIGATOR)
Moussa Saleh, MD (SUB_INVESTIGATOR)
Lenox Hill HospitalNew YorkNew York10075
Kristie Coleman
[email protected]
Nicholas Skipitaris, MD (SUB_INVESTIGATOR)
Staten Island University HospitalStaten IslandNew York10305
Alexandra Pantea
[email protected]
Marcin Kowalski, MD (SUB_INVESTIGATOR)
Valay Parikh, MD (SUB_INVESTIGATOR)
Samer Saouma, MD (SUB_INVESTIGATOR)
Rina Shah, MD (SUB_INVESTIGATOR)

Find similar trials in Bay Shore, NY

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
South Shore University Hospital· Bay Shore, NYHuntington Hospital· Huntington, NYNorth Shore University Hospital· Manhasset, NYLong Island Jewish Medical Center· New Hyde Park, NYLenox Hill Hospital· New York, NYStaten Island University Hospital· Staten Island, NY

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