Aveir Dual-Chamber Leadless i2i IDE Study
Aveir Dual-Chamber Leadless i2i IDE Study
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
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.
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
Inclusion Criteria:
Exclusion Criteria:
San Diego, California 92118-8411, United States
Winston-Salem, North Carolina 27157, United States
Kurashiki-shi, Okayama-ken, Japan