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NCT01314313 · ClinicalTrials.gov registry record · NA
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
A NA study, sponsored by Edwards Lifesciences.
- Completed
- Registry status
- NA
- Development phase
- 2,032
- Enrollment target
NCT01314313: Completed NA study, sponsored by Edwards Lifesciences.
NCT01314313 is a NA study that has completed, run by Edwards Lifesciences. The registered enrollment target is 2,032 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (45% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01314313, a NA study, has completed, sponsored by Edwards Lifesciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 2,032 participants
- Enrollment target
Study Summary
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.
Primary Outcome
All-cause Death or Disabling Stroke (Edwards SAPIEN XT THV vs SAVR)
Interventions
- DEVICE TAVR Implantation with SAPIEN XT
- DEVICE SAVR Implantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,032 participants |
| Start Date | 2011-03 |
| Est. Completion | 2024-01-17 |
| Phase | NA |
What the finished NCT01314313 record still lists
NCT01314313 is an interventional study that assigns participants to a tested intervention. Its 2,032 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (45% higher).
The record links to 0 conditions, and to 2 interventions - of which TAVR Implantation with SAPIEN XT is the first listed.
NCT01314313 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01314313 about?
NCT01314313 is a clinical study titled "PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk". The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.
What is the current status of trial NCT01314313?
This trial is currently completed. It is a NA study. The enrollment target is 2,032 participants. The study started on 2011-03. Estimated completion is 2024-01-17.
What interventions are being tested in trial NCT01314313?
The interventions under investigation include: TAVR Implantation with SAPIEN XT (DEVICE), SAVR Implantation (DEVICE).
Who is sponsoring clinical trial NCT01314313?
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 NCT01314313's enrollment target sits among peer trials
2,032 52nd of 2000 higher than 1,949 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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