At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,276 enrolled
Drug / intervention
Aveir VR 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.
The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System
In Brief
A clinical study evaluating Aveir VR Leadless Pacemaker System for Cardiac Rhythm Disorder and Bradycardia. Completed, enrolled 1,276 participants across 53 sites in 8 countries.
Detailed Summary
prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Rhythm Disorder, Bradycardia
CountriesCanada, Czechia, France, Italy, Netherlands, Spain, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedSep 2020
Enrollment StartNov 2020
Primary CompletionJul 2022
Study CompletionSep 2023
TodayJul 2026
First PostedSep 23, 2020
Enrollment StartNov 13, 2020
Primary CompletionJul 18, 2022
Study CompletionSep 15, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.8 years ago
Interventions
Aveir VR Leadless Pacemaker Systemdevice
Patients will undergo an attempted leadless pacemaker implant