Aveir DR i2i Study
Completed · Not applicable
Conditions studied: Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder, Bradycardia
In brief
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
Key facts
- Study ID
- NCT05252702
- Run by
- Abbott Medical Devices
- People needed
- 464
- Starts
- 2022-02-02
- Expected to finish
- 2026-02-03
- Last updated by the study team
- 2026-05-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject must have at least one of the clinical indications before device implant in adherence with ACC/AHA/HRS/ESC dual chamber pacing guidelines
- Subject is ≥ 18 years of age or age of legal consent, whichever age is greater
- Subject has a life expectancy of at least one year
- Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
- 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
You may not qualify if…
- Subject is currently participating in another clinical investigation that may confound the results of this study as determined by the Sponsor
- Subject is pregnant or nursing and those who plan pregnancy during the clinical investigation follow-up period
- 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
- 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
- Subject has an implanted vena cava filter or mechanical tricuspid valve prosthesis
- Subject has pre-existing, permanent endocardial pacing or defibrillation leads (does not include lead fragments)
- Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
- Subject has an implanted leadless cardiac pacemaker (except for an Aveir ventricular leadless pacemaker)
- Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators)
- Subject is unable to read or write
Where it is running
- 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
- HonorHealth — Scottsdale, Arizona, United States
Full record on ClinicalTrials.gov
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