Trials / Completed
CompletedNCT03417011
FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 638 (actual)
- Sponsor
- Medtronic Cardiovascular · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Prospective, single-arm, multi-center, interventional post-market study. After signing informed consent, eligible subjects will be implanted with the CE marked Evolut™ PRO system. The investigation purpose is to evaluate the acute and long term clinical performance and safety of Evolut™ PRO in a routine hospital setting in patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement within the approved intended use in local geography.
Detailed description
Approximately 600 subjects implanted with the Evolut™ PRO at up to 40 sites in Europe. Other regions may be added depending on the regulatory status of the device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Medtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System) | Transcatheter Aortic Valve Replacement with Medtronic Evolut PRO system |
Timeline
- Start date
- 2018-02-26
- Primary completion
- 2019-03-06
- Completion
- 2024-02-26
- First posted
- 2018-01-31
- Last updated
- 2025-09-09
Locations
39 sites across 14 countries: Austria, Belgium, Denmark, Finland, France, Germany, Israel, Italy, Netherlands, Norway, Slovenia, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT03417011. Inclusion in this directory is not an endorsement.