At a glance
ClinicalIndex Comparison RecordN/ACompleted· 464 enrolled
Drug / intervention
Aveir DR Leadless Pacemaker Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Aveir Dual-Chamber Leadless i2i IDE Study
In Brief
A clinical study evaluating Aveir DR Leadless Pacemaker System for Cardiac Pacemaker, Artificial and 2 related conditions. Completed, enrolled 464 participants across 78 sites in 13 countries.
Detailed Summary
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, Canada, Czechia, France, Hong Kong, Italy, Japan, Netherlands, Spain, Taiwan, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
20222023202420252026
Enrollment StartFeb 2022
First PostedFeb 2022
Primary CompletionAug 2023
Study CompletionFeb 2026
TodayJul 2026
First PostedFeb 23, 2022
Enrollment StartFeb 2, 2022
Primary CompletionAug 2, 2023
Study CompletionFeb 3, 2026
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.4 years ago
Interventions
Aveir DR Leadless Pacemaker Systemdevice
Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium