The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System

Abbott

Status: Active, not recruiting

Conditions: Bradycardia; Cardiac Rhythm Disorder

Treatments: Device: Aveir VR Leadless Pacemaker System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04559945

SJM-CIP-10226

Details and patient eligibility

About

prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.

Enrollment: 326 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject must have one of the clinical indications before device implant in adherence with Medicare, ACC/AHA/HRS/ESC single chamber pacing guidelines including:

   • Chronic and/or permanent atrial fibrillation with 2° or 3° AV or bifascicular bundle branch block (BBB block), including slow ventricular rates (with or without medication) associated with atrial fibrillation; or
   • Normal sinus rhythm with 2° or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or
   • Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and

2. Subject is ≥18 years of age; and

3. Subject has a life expectancy of at least one year; and

4. Subject is not enrolled in another clinical investigation; and

5. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and

6. Subject has been informed of the nature of the study, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC; and

7. Subject is not pregnant and does not plan to get pregnant during the course of the study.

Exclusion criteria

1. Subject has known pacemaker syndrome, has retrograde VA conduction, or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or
2. Subject is allergic or hypersensitive to < 1 mg of dexamethasone sodium phosphate (DSP);
3. Subject has a mechanical tricuspid valve prosthesis; or
4. Subject has a pre-existing endocardial pacing or defibrillation leads; or
5. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device; or
6. Subject has an implanted vena cava filter; or
7. Subject has evidence of thrombosis in one of the veins used for access during the procedure; or
8. Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment; or
9. Subject has an implanted leadless cardiac pacemaker or
10. Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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326 participants in 1 patient group

Aveir VR Leadless Pacemaker

Experimental group

Description:

VVIR pacing

Treatment:

Device: Aveir VR Leadless Pacemaker System