The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker
- Conditions
- Bradycardia
- Interventions
- Device: Leadless Pacemaker
- Registration Number
- NCT02030418
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
Prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR pacemaker.
Following completion of enrollments in the IDE, patients will continue to be enrolled in the continued access phase of the study under the same protocol.
- Detailed Description
The purpose of this study is to evaluate the safety and effectiveness of the leadless pacemaker system in treating patients with a slow heart rate or irregular heartbeats. The Nanostim leadless pacemaker provides bradycardia pacing as a pulse generator with built-in battery and electrodes, for permanent implantation in the right ventricle. As a leadless pacemaker, it does not need a connector, pacing lead, or pulse generator pocket, but it has the same operating principles as a conventional pacemaker.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 526
-
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 ≥18 years of age; and
-
Subject has 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 written informed consent, approved by the IRB; and
-
Subject is not pregnant and does not plan to get pregnant during the course of the study.
- Subject has 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; or
- 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); 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 has an implanted leadless cardiac pacemaker; or
- Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Leadless Pacemaker Leadless Pacemaker VVIR pacing
- Primary Outcome Measures
Name Time Method Pacing thresholds and R-wave amplitudes within the therapeutic range 6 months Complication-Free Rate 6 months
- Secondary Outcome Measures
Name Time Method appropriate and proportional rate response during graded exercise testing 3-6 months
Trial Locations
- Locations (59)
El Camino Hospital
🇺🇸Mountain View, California, United States
Premier Cardiology, Inc
🇺🇸Newport Beach, California, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Huntington Memorial Hospital
🇺🇸Pasadena, California, United States
WellSpan Health
🇺🇸York, Pennsylvania, United States
Vancouver General Hospital (U of BC)
🇨🇦Vancouver, British Columbia, Canada
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
St. John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
Heart Center Research, LLC.
🇺🇸Huntsville, Alabama, United States
University Hospital - Univ. of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
USC University Hospital
🇺🇸Los Angeles, California, United States
Scripps Health
🇺🇸La Jolla, California, United States
Sequoia Hospital
🇺🇸Redwood City, California, United States
Naples Community Hospital
🇺🇸Naples, Florida, United States
South Denver Cardiology Associates PC
🇺🇸Littleton, Colorado, United States
Piedmont Athens Regional Medical Center
🇺🇸Athens, Georgia, United States
Parkview Research Center
🇺🇸Fort Wayne, Indiana, United States
Redmond Regional Medical Center
🇺🇸Rome, Georgia, United States
St. Elizabeth Medical Center
🇺🇸Edgewood, Kentucky, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
Lahey Clinic Medical Center
🇺🇸Burlington, Massachusetts, United States
Sparrow Research
🇺🇸Lansing, Michigan, United States
Munson Medical Center
🇺🇸Traverse, Michigan, United States
Michigan Heart
🇺🇸Ypsilanti, Michigan, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Mercy Hospital St. Louis
🇺🇸Saint Louis, Missouri, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
New York Presbyterian Hospital/Cornell University
🇺🇸New York, New York, United States
Cardiac Arrhythmia and Pacemaker Center
🇺🇸Roslyn, New York, United States
Cone Health Medical Group HeartCare
🇺🇸Greensboro, North Carolina, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Methodist University Hospital
🇺🇸Memphis, Tennessee, United States
South Texas Cardiovascular Consultants
🇺🇸San Antonio, Texas, United States
Clinical Tex Research, LLC
🇺🇸Amarillo, Texas, United States
Intermountain Heart Rhythm Specialists
🇺🇸Murray, Utah, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
The Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
Kinsgston General Hospital
🇨🇦Kingston, Ontario, Canada
Institut de Cardiologie de Quebec (Hospital Laval)
🇨🇦Quebec, Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
🇨🇦Montreal, Quebec, Canada
Southlake Regional Health Centre
🇨🇦Newmarket, Ontario, Canada
Mount Sinai Hospital
🇺🇸New York, New York, United States
Mercy Medical Group - Cardiology
🇺🇸Sacramento, California, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Orlando Health
🇺🇸Orlando, Florida, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Aurora Medical Group
🇺🇸Milwaukee, Wisconsin, United States