The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System
- Conditions
- Cardiac Rhythm DisorderBradycardia
- Interventions
- Device: Aveir VR Leadless Pacemaker System
- Registration Number
- NCT04559945
- Lead Sponsor
- Abbott Medical Devices
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 326
-
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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Aveir VR Leadless Pacemaker Aveir VR Leadless Pacemaker System VVIR pacing
- Primary Outcome Measures
Name Time Method Complication-Free Rate 12 months Pacing thresholds and R-wave amplitudes within the therapeutic range 12 months
- Secondary Outcome Measures
Name Time Method Survival Rate of Patients implanted with the Nanostim Leadless Pacemaker 2 years Appropriate and proportional rate response during graded exercise testing 3 month follow up
Trial Locations
- Locations (53)
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
WellSpan Health
🇺🇸York, Pennsylvania, United States
Kinsgston General Hospital
🇨🇦Kingston, Ontario, Canada
University of Southern California
🇺🇸Long Beach, California, United States
Huntington Memorial Hospital
🇺🇸Pasadena, California, United States
HSC, Eastern Health
🇨🇦Saint John's, Newfoundland and Labrador, Canada
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Kansas City Cardiac Arrhythmia Research Foundation
🇺🇸Overland Park, Kansas, United States
Ascension St. John Hospital
🇺🇸Detroit, Michigan, United States
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Utah Hospital
🇺🇸Salt Lake City, Utah, United States
Lahey Clinic Medical Center
🇺🇸Burlington, Massachusetts, United States
New York Presbyterian Hospital/Cornell University
🇺🇸New York, New York, United States
Sparrow Clinical Research Institute
🇺🇸Lansing, Michigan, United States
Cone Health Medical Group HeartCare
🇺🇸Greensboro, North Carolina, United States
CHRU Albert Michallon
🇫🇷Grenoble, France
The Heart Center PC
🇺🇸Huntsville, Alabama, United States
Honor Health
🇺🇸Scottsdale, Arizona, United States
St. Elizabeth Medical Center - South Unit
🇺🇸Edgewood, Kentucky, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
Redmond Regional Medical Center
🇺🇸Rome, Georgia, United States
Southlake Regional Health Centre
🇨🇦Newmarket, Ontario, Canada
South Texas Cardiovascular Consultants
🇺🇸San Antonio, Texas, United States
Methodist University Hospital
🇺🇸Memphis, Tennessee, United States
Na Homolce Hospital
🇨🇿Praha, Czechia
Mount Sinai Hospital
🇺🇸New York, New York, United States
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
🇨🇦Montreal, Quebec, Canada
CHRU Hopital de Pontchaillou
🇫🇷Rennes, France
Amsterdam Academic Medical Centre (AMC)
🇳🇱Amsterdam, Netherlands
Hopital d'adulte de la Timone
🇫🇷Marseille, France
Institut de Cardiologie de Quebec (Hospital Laval)
🇨🇦Québec, Quebec, Canada
Isala - ZWolle
🇳🇱Zwolle, Netherlands
Centro Cardiologico Monzino
🇮🇹Milano, Italy
Hospital Universitario Infanta Cristina
🇪🇸Badajoz, Spain
Mercy Hospital St. Louis
🇺🇸Saint Louis, Missouri, United States
Piedmont Athens Regional Medical Center
🇺🇸Athens, Georgia, United States
Naples Heart Rhythm Specialists PA
🇺🇸Naples, Florida, United States
Premier Cardiology Inc
🇺🇸Newport Beach, California, United States
South Denver Cardiology Associates PC
🇺🇸Littleton, Colorado, United States
Jersey Shore University Medical Center
🇺🇸Ocean Township, New Jersey, United States
Memorial Hermann Hospital
🇺🇸The Woodlands, Texas, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Cardiac Arrhythmia & Pacemaker Center
🇺🇸Roslyn, New York, United States
University Hospital - University of Alabama at Birmingham (UAB)
🇺🇸Birmingham, Alabama, United States
Orlando Health
🇺🇸Orlando, Florida, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Royal Brompton Hospital
🇬🇧London, United Kingdom