The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System
NCT ID: NCT04559945
Last Updated: 2022-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
326 participants
INTERVENTIONAL
2020-11-13
2023-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Aveir VR Leadless Pacemaker
VVIR pacing
Aveir VR Leadless Pacemaker System
Patients will undergo an attempted leadless pacemaker implant
Interventions
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Aveir VR Leadless Pacemaker System
Patients will undergo an attempted leadless pacemaker implant
Eligibility Criteria
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Inclusion Criteria
* 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
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).
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Reddy VY, Exner DV, Doshi R, Tomassoni G, Bunch TJ, Friedman P, Estes NAM, Neuzil P, de la Concha JF, Cantillon DJ; LEADLESS II Investigators. 1-Year Outcomes of a Leadless Ventricular Pacemaker: The LEADLESS II (Phase 2) Trial. JACC Clin Electrophysiol. 2023 Jul;9(7 Pt 2):1187-1189. doi: 10.1016/j.jacep.2023.01.031. Epub 2023 Mar 22. No abstract available.
Other Identifiers
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SJM-CIP-10226
Identifier Type: -
Identifier Source: org_study_id