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ACTIVE NOT RECRUITING

NCT04559945

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

Sponsor: Abbott Medical Devices

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

326

Start Date

2020-11-13

Completion Date

2023-08-31

Last Updated

2022-12-19

Healthy Volunteers

Conditions

Cardiac Rhythm Disorder Bradycardia

Interventions

DEVICE

Aveir VR Leadless Pacemaker System

Patients will undergo an attempted leadless pacemaker implant

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

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

Mount Sinai Hospital

New York, New York, United States

Cardiac Arrhythmia & Pacemaker Center

Roslyn, New York, United States

Cone Health Medical Group HeartCare

Greensboro, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Integris Baptist Medical Center

Oklahoma City, Oklahoma, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

WellSpan Health

York, Pennsylvania, United States

Methodist University Hospital

Memphis, Tennessee, United States

South Texas Cardiovascular Consultants

San Antonio, Texas, United States

Memorial Hermann Hospital

The Woodlands, Texas, United States

University of Utah Hospital

Salt Lake City, Utah, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Foothills Medical Centre

Calgary, Alberta, Canada

HSC, Eastern Health

St. John's, Newfoundland and Labrador, Canada

Kinsgston General Hospital

Kingston, Ontario, Canada

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, Quebec, Canada

Institut de Cardiologie de Quebec (Hospital Laval)

Québec, Quebec, Canada

Na Homolce Hospital

Prague, Czechia

CHRU Albert Michallon

Grenoble, France

Hopital d'adulte de la Timone

Marseille, France

CHRU Hopital de Pontchaillou

Rennes, France

Centro Cardiologico Monzino

Milan, Italy

Amsterdam Academic Medical Centre (AMC)

Amsterdam, Netherlands

Isala - ZWolle

Zwolle, Netherlands

Hospital Universitario Infanta Cristina

Badajoz, Spain

Royal Brompton Hospital

London, United Kingdom