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NCT03225001 · ClinicalTrials.gov registry record · NA
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve
A NA study, sponsored by Edwards Lifesciences.
- Completed
- Registry status
- NA
- Development phase
- 197
- Enrollment target
NCT03225001: Completed NA study, sponsored by Edwards Lifesciences.
NCT03225001 is a NA study that has completed, run by Edwards Lifesciences. The registered enrollment target is 197 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03225001, a NA study, has completed, sponsored by Edwards Lifesciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 197 participants
- Enrollment target
Study Summary
To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.
Primary Outcome
The primary endpoint of all-cause mortality, all stroke, moderate or severe obstruction, or moderate or severe paravalvular leak
Interventions
- DEVICE Edwards SAPIEN XT transcatheter valve, Model 9300TFX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2012-06-11 |
| Est. Completion | 2020-10-28 |
| Phase | NA |
What the finished NCT03225001 record still lists
NCT03225001 is an interventional study that assigns participants to a tested intervention. The registered 197 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Edwards SAPIEN XT transcatheter valve, Model 9300TFX is the first listed.
NCT03225001 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03225001 about?
NCT03225001 is a clinical study titled "PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve". To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.
What is the current status of trial NCT03225001?
This trial is currently completed. It is a NA study. The enrollment target is 197 participants. The study started on 2012-06-11. Estimated completion is 2020-10-28.
What interventions are being tested in trial NCT03225001?
The interventions under investigation include: Edwards SAPIEN XT transcatheter valve, Model 9300TFX (DEVICE).
Who is sponsoring clinical trial NCT03225001?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03225001's enrollment target sits among peer trials
197 567th of 2000 higher than 1,434 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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