Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
464 participants
INTERVENTIONAL
2022-02-02
2025-11-30
Brief Summary
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Detailed Description
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Subjects participating in the study are followed through at least 12 months with data collected at baseline, implant procedure, pre (hospital) discharge, and follow-up at 1 month, 3 months, 6 months, 12 months, and every 6 months thereafter until study completion
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
Non randomized arm
Aveir DR Leadless Pacemaker System
Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium
Interventions
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Aveir DR Leadless Pacemaker System
Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium
Eligibility Criteria
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Inclusion Criteria
2. Subject is ≥ 18 years of age or age of legal consent, whichever age is greater
3. Subject has a life expectancy of at least one year
4. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
5. Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC
Exclusion Criteria
2. Subject is pregnant or nursing and those who plan pregnancy during the clinical investigation follow-up period
3. Subject has presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could confound the assessment of the investigational device and/or implant procedure, limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results
4. Subject has a known allergy or hypersensitivity to \< 1 mg of dexamethasone sodium phosphate or any blood or tissue contacting material listed in the IFU
5. Subject has an implanted vena cava filter or mechanical tricuspid valve prosthesis
6. Subject has pre-existing, permanent endocardial pacing or defibrillation leads (does not include lead fragments)
7. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
8. Subject has an implanted leadless cardiac pacemaker (except for an Aveir ventricular leadless pacemaker)
9. Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators)
10. Subject is unable to read or write
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Nicole Harbert
Role: STUDY_DIRECTOR
Abbott
Locations
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HonorHealth
Scottsdale, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
USC University Hospital
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Premier Cardiology, Inc
Newport Beach, California, United States
Providence Medical Foundation
Orange, California, United States
Huntington Memorial Hospital
Pasadena, California, United States
University of California at San Diego (UCSD) Medical Center
San Diego, California, United States
Pacific Heart Institute
Santa Monica, California, United States
South Denver Cardiology Associates PC
Littleton, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Baptist Medical Center
Jacksonville, Florida, United States
Naples Heart Rhythm Specialists, PA
Naples, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Prairie Education & Research Cooperative
Springfield, Illinois, United States
Iowa Heart Center
West Des Moines, Iowa, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Charlton Memorial Hospital
Fall River, Massachusetts, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
Providence Hospital
Southfield, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Bryan Heart
Lincoln, Nebraska, United States
Catholic Medical Center
Manchester, New Hampshire, United States
Jersey Shore University Medical Center
Ocean City, New Jersey, United States
North Shore University Hospital
Manhasset, New York, United States
New York University Hospital
New York, New York, United States
New York Presbyterian Hospital/Cornell University
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
New York-Presbyterian/Columbia University Medical Center
New York, New York, United States
Cardiac Arrhythmia & Pacemaker Center
Roslyn, New York, United States
Wake Forest University Medical Center Clinical Sciences
Winston-Salem, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio Health Research Institute
Columbus, Ohio, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital South
Oklahoma City, Oklahoma, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Donald Guthrie Foundation for Education & Research
Sayre, Pennsylvania, United States
Sanford USD Medical Center
Sioux Falls, South Dakota, United States
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia
Austin, Texas, 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
Franciscan Heart & Vascular Associates
Tacoma, Washington, United States
Aurora Medical Group
Milwaukee, Wisconsin, United States
Aspirus Wausau Hospital
Wausau, Wisconsin, United States
Kepler Universitätsklinikum GmbH
Linz, Upper Austria, Austria
UZ Gasthuisberg
Leuven, Flemish Brabant, Belgium
Foothills Medical Centre
Calgary, Alberta, Canada
HSC, Eastern Health
St. John's, Newfoundland and Labrador, Canada
QE II Health Sciences
Halifax, Nova Scotia, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, Canada
Nemocnice Na Homolce
Prague, , Czechia
Hopital d'adulte de la Timone
Marseille, Alpes, France
CHRU Albert Michallon
Grenoble, , France
Prince of Wales Hospital
Hong Kong, HK SAR, Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
Centro Cardiologico Monzino
Milan, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
Kurashiki Central Hospital
Kurashiki-shi, Okayama-ken, Japan
National Cerebral & Cardiovascular Center Hospital
Suita, Osaka, Japan
Tokyo Women's Medical University
Tokyo, , Japan
Amsterdam Academic Medical Centre (AMC)
Amsterdam, , Netherlands
Hospital Universitario de Badajoz
Badajoz, Extmdra, Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
National Taiwan University Hospital
Taipei, , Taiwan
John Radcliffe Hospital
Oxford, Soeast, United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Countries
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References
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Knops RE, Ip JE, Doshi R, Exner DV, Defaye P, Canby R, Bongiorni MG, Shoda M, Hindricks G, Neuzil P, Rashtian M, Breeman KTN, Nevo JR, Ganz L, Hubbard C, Bulusu A, Reddy VY. One-Year Safety and Performance of a Dual-Chamber Leadless Pacemaker. Circ Arrhythm Electrophysiol. 2025 Apr;18(4):e013619. doi: 10.1161/CIRCEP.124.013619. Epub 2025 Mar 27.
Doshi RN, Ip JE, Defaye P, Reddy VY, Exner DV, Canby R, Shoda M, Bongiorni MG, Hindricks G, Neuzil P, Callahan T, Sundaram S, Booth DF, Richer LP, Badie N, Knops RE. Dual-chamber leadless pacemaker implant procedural outcomes: Insights from the AVEIR DR i2i study. Heart Rhythm. 2025 Sep;22(9):2391-2400. doi: 10.1016/j.hrthm.2025.03.1941. Epub 2025 Mar 13.
Rashtian MY, Ip JE, Exner DV, Reddy VY, Doshi RN, Defaye P, Canby RC, Bongiorni MG, Shoda M, Hindricks G, Nevo JR, Ligon D, Bulusu A, Knops RE. Temperature-based rate response in a leadless pacemaker system. Heart Rhythm. 2025 Jun;22(6):1533-1540. doi: 10.1016/j.hrthm.2024.11.032. Epub 2024 Nov 22.
Doshi RN, Ip JE, Defaye P, Exner DV, Reddy VY, Hindricks G, Canby R, Shoda M, Bongiorni MG, Neuzil P, Callahan T, Badie N, Ligon D, Knops RE. Chronic wireless communication between dual-chamber leadless pacemaker devices. Heart Rhythm. 2025 Apr;22(4):1010-1020. doi: 10.1016/j.hrthm.2024.10.020. Epub 2024 Oct 19.
Knops RE, Reddy VY, Ip JE, Doshi R, Exner DV, Defaye P, Canby R, Bongiorni MG, Shoda M, Hindricks G, Neuzil P, Rashtian M, Breeman KTN, Nevo JR, Ganz L, Hubbard C, Cantillon DJ; Aveir DR i2i Study Investigators. A Dual-Chamber Leadless Pacemaker. N Engl J Med. 2023 Jun 22;388(25):2360-2370. doi: 10.1056/NEJMoa2300080. Epub 2023 May 20.
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.
Provided Documents
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Document Type: Study Protocol: Clinical Investigation Plan
Document Type: Study Protocol: Clinical Investigation Plan for Europe
Document Type: Statistical Analysis Plan: Statistical Analysis Plan
Document Type: Statistical Analysis Plan: Statistical Analysis Plan for Europe
Other Identifiers
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ABT-CIP-10416
Identifier Type: -
Identifier Source: org_study_id
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