Single Chamber Atrial Leadless Pacing for Isolated Sinus Node Dysfunction
ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNorthwell Health
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Atrioventricular block
Bundle branch block
History of atrial fibrillation
Carotid sinus hypersensitivity
Trial design
Treatments tested in this trial
- Implantable Loop Recorder
Treatment groups
No treatment groups listed
Sponsors and collaborators
Northwell Health
Lead sponsor
Abbott
Collaborator
Source ClinicalTrials.gov