Trials / Completed
CompletedNCT04091048
Optimize PRO Study
Optimize PRO Transcatheter Aortic Valve Replacement Post Market Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,127 (actual)
- Sponsor
- Medtronic Cardiovascular · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and Evolut™ PRO+ devices. The purpose of the addendum is to collect post-market clinical evidence on valve performance and procedural outcomes associated with the Evolut FX Device.
Detailed description
This is a post market, multi-center (sites in US/CAN/EMEA/ANZ), prospective, non-randomized study. The addendum is a post market, multi-center (sites in US only), prospective, non-randomized study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum) | Aortic valve replacement |
Timeline
- Start date
- 2019-09-16
- Primary completion
- 2023-12-15
- Completion
- 2024-11-13
- First posted
- 2019-09-16
- Last updated
- 2026-01-13
- Results posted
- 2025-02-06
Locations
60 sites across 12 countries: United States, Australia, Belgium, Canada, France, Germany, Ireland, Israel, Italy, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04091048. Inclusion in this directory is not an endorsement.