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

Completed · Not applicable

Conditions studied: Cardiac Rhythm Disorder, Bradycardia

In brief

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.

Key facts

Study ID

NCT04559945

Run by

Abbott Medical Devices

People needed

1276

Starts

2020-11-13

Expected to finish

2023-09-15

Last updated by the study team

2026-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Subject is ≥18 years of age; and
• Subject has a life expectancy of at least one year; and
• Subject is not enrolled in another clinical investigation; and
• Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
• 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
• Subject is not pregnant and does not plan to get pregnant during the course of the study.

You may not qualify if…

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

Where it is running

• 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
• Redmond Regional Medical Center — Rome, Georgia, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Kansas City Cardiac Arrhythmia Research Foundation — Overland Park, Kansas, United States
• St. Elizabeth Medical Center - South Unit — Edgewood, Kentucky, United States
• Baptist Health Lexington — Lexington, Kentucky, United States
• University of Kentucky — Lexington, Kentucky, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Lahey Clinic Medical Center — Burlington, Massachusetts, United States
• Ascension St. John Hospital — Detroit, Michigan, United States
• Sparrow Clinical Research Institute — Lansing, Michigan, United States
• Munson Medical Center — Traverse City, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Mercy Hospital St. Louis — St Louis, Missouri, United States
• Jersey Shore University Medical Center — Ocean Township, New Jersey, United States
• New York Presbyterian Hospital/Cornell University — New York, New York, United States
• University Hospital - University of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.