Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Incidence of atrial fibrillation

Incidence of atrial fibrillation in patients implanted with a single chamber (Aveir AR, Abbott) leadless pacemaker and a loop recorder.

Time frame
24 months

Secondary outcomes

1

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

Time frame
24 months
2

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.

Time frame
24 months
3

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.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwell Health

Lead sponsor

Abbott

Collaborator

Source ClinicalTrials.gov
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