Trial Details
Aveir Dual-Chamber Leadless i2i IDE Study
NCT05252702
ACTIVE_NOT_RECRUITING
DESCRIPTION
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
CONDITIONS
Cardiac Pacemaker, Artificial Cardiac Rhythm Disorder Bradycardia
ELIGIBILITY CRITERIA
- Inclusion Criteria
- :
1. Subject must have at least one of the clinical indications before device implant in adherence with ACC/AHA/HRS/ESC dual chamber pacing guidelines
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
