Status:
ACTIVE_NOT_RECRUITING
Aveir DR i2i Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Cardiac Pacemaker, Artificial
Cardiac Rhythm Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
Detailed Description
The purpose of this clinical investigation is to evaluate the clinical safety and effectiveness of the Aveir DR Leadless Pacemaker system in a patient population indicated for a DDD(R) pacemaker. Sub...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2025
Estimated Enrollment :
464 Patients enrolled
Trial Details
Trial ID
NCT05252702
Start Date
February 2 2022
End Date
November 1 2025
Last Update
August 15 2025
Active Locations (78)
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1
HonorHealth
Scottsdale, Arizona, United States, 85258
2
Arrhythmia Research Group
Jonesboro, Arkansas, United States, 72401
3
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
4
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027