Trials / Terminated
TerminatedNCT04639258
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Medtronic Cardiovascular · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.
Detailed description
Single-arm, descriptive, multi-center, international All subjects will be treated with a Medtronic Evolut™ PRO+ TAVR System. Subject follow-ups will be conducted at pre and post-procedure, discharge, 30 days, 6 months, and annually through 5 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Medtronic Evolut™ PRO+ System | TAVR treatment with Medtronic Evolut™ PRO+ System |
Timeline
- Start date
- 2021-05-28
- Primary completion
- 2022-06-07
- Completion
- 2022-06-07
- First posted
- 2020-11-20
- Last updated
- 2024-01-10
- Results posted
- 2024-01-10
Locations
8 sites across 5 countries: United States, Australia, Canada, Israel, New Zealand
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04639258. Inclusion in this directory is not an endorsement.