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The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System | Clinical Trials | Clareo Health

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

The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System

NCT04559945•Abbott Medical Devices

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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).

Locations (53)

University Hospital - University of Alabama at Birmingham (UAB)

Birmingham, Alabama, United States

The Heart Center PC

Huntsville, Alabama, United States

Honor Health

Scottsdale, Arizona, United States

University of Southern California

Long Beach, California, United States

Premier Cardiology Inc

Newport Beach, California, United States

Huntington Memorial Hospital

Pasadena, California, United States

South Denver Cardiology Associates PC

Littleton, Colorado, United States

Naples Heart Rhythm Specialists PA

Naples, Florida, United States

Orlando Health

Orlando, Florida, United States

Piedmont Athens Regional Medical Center

Athens, Georgia, United States

Key Dates

Start Date

November 13, 2020

Primary Completion Date

July 18, 2022

Completion Date

August 31, 2023

Last Updated

December 19, 2022

Enrollment

326

ACTUAL participants

Conditions

Cardiac Rhythm DisorderBradycardia

Interventions

Aveir VR Leadless Pacemaker System

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Product Surveillance Registry

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