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NCT01700439 · ClinicalTrials.gov registry record · NA
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
A NA study, sponsored by Edwards Lifesciences.
- Completed
- Registry status
- NA
- Development phase
- 934
- Enrollment target
NCT01700439: Completed NA study, sponsored by Edwards Lifesciences.
NCT01700439 is a NA study that has completed, run by Edwards Lifesciences. The registered enrollment target is 934 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01700439, a NA study, has completed, sponsored by Edwards Lifesciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 934 participants
- Enrollment target
Study Summary
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.
Primary Outcome
Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:\[(Number of late adverse events/sum of late patient years) x 100\]
Interventions
- DEVICE EDWARDS INTUITY valve
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 934 participants |
| Start Date | 2012-09-26 |
| Est. Completion | 2021-05-26 |
| Phase | NA |
What the finished NCT01700439 record still lists
NCT01700439 is an interventional study that assigns participants to a tested intervention. The registered 934 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 (33% lower).
The record links to 0 conditions, and to 1 intervention - of which EDWARDS INTUITY valve is the first listed.
NCT01700439 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01700439 about?
NCT01700439 is a clinical study titled "Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve". The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.
What is the current status of trial NCT01700439?
This trial is currently completed. It is a NA study. The enrollment target is 934 participants. The study started on 2012-09-26. Estimated completion is 2021-05-26.
What interventions are being tested in trial NCT01700439?
The interventions under investigation include: EDWARDS INTUITY valve (DEVICE).
Who is sponsoring clinical trial NCT01700439?
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 NCT01700439's enrollment target sits among peer trials
934 123rd of 2000 higher than 1,878 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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