Trials / Active Not Recruiting
Active Not RecruitingNCT04559945
The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System
The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 326 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Aveir VR Leadless Pacemaker System | Patients will undergo an attempted leadless pacemaker implant |
Timeline
- Start date
- 2020-11-13
- Primary completion
- 2022-07-18
- Completion
- 2023-08-31
- First posted
- 2020-09-23
- Last updated
- 2022-12-19
Locations
53 sites across 8 countries: United States, Canada, Czechia, France, Italy, Netherlands, Spain, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04559945. Inclusion in this directory is not an endorsement.