Trials / Completed
CompletedNCT01238835
PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 220 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery system, and crimper accessories.
Detailed description
Purpose: The purpose of this trial is to evaluate the acute safety and effectiveness of the SAPIEN XT™ study valve and next generation Ascendra™ delivery components. Follow-up Intervals: Subject data collection will include clinical information at baseline and during the index procedure. Subjects will undergo clinical follow-up at discharge, 30 days, 6 month annually for 5 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SAPIEN XT™ Transapical aortic valve replacement | Transcatheter aortic valve implantation via the transapical approach |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2011-02-01
- Completion
- 2016-03-01
- First posted
- 2010-11-11
- Last updated
- 2020-11-02
- Results posted
- 2020-11-02
Locations
20 sites across 4 countries: Austria, France, Germany, United Kingdom
Source: ClinicalTrials.gov record NCT01238835. Inclusion in this directory is not an endorsement.