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NCT01940120 · ClinicalTrials.gov registry record · NA
EVEREST II Pivotal Study High Risk Registry (HRR)
A NA study, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 78
- Enrollment target
NCT01940120: Completed NA study, sponsored by Abbott Medical Devices.
NCT01940120 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 78 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01940120, a NA study, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 78 participants
- Enrollment target
Study Summary
Prospective, multi-center, single arm registry. Clinical follow-up at discharge, 30 days, 6, 12, 18 and 24, months, and 3, 4 and 5 years. Concurrent Control (CC) group identified retrospectively from the patients screened for the HRR who did not enroll; patient survival determined at 12 months. NCT00209274 (EVEREST II RCT) Intended use Percutaneous reduction of clinically significant mitral regurgitation in symptomatic patients who are considered to be high risk for operative mortality (high surgical risk).
Primary Outcome
Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories: A. Cardiac death is defined as death due to any of the following: 1. Acute myocardial infarction. 2. Cardiac perforation/pericardial tamponade. 3. Arrhythmia or conduction abnormality. 4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure. 5. Death due to any complication of the procedure, including bleeding, vascular re
Interventions
- DEVICE Percutaneous mitral valve repair using MitraClip implant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2007-02 |
| Est. Completion | 2013-02 |
| Phase | NA |
What the finished NCT01940120 record still lists
NCT01940120 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Percutaneous mitral valve repair using MitraClip implant is the first listed.
NCT01940120 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01940120 about?
NCT01940120 is a clinical study titled "EVEREST II Pivotal Study High Risk Registry (HRR)". Prospective, multi-center, single arm registry. Clinical follow-up at discharge, 30 days, 6, 12, 18 and 24, months, and 3, 4 and 5 years. Concurrent Control (CC) group identified retrospectively from the patients screened for the HRR who did not enroll; patient survival determined at 12 months. NCT...
What is the current status of trial NCT01940120?
This trial is currently completed. It is a NA study. The enrollment target is 78 participants. The study started on 2007-02. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01940120?
The interventions under investigation include: Percutaneous mitral valve repair using MitraClip implant (DEVICE).
Who is sponsoring clinical trial NCT01940120?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01940120's enrollment target sits among peer trials
78 1060th of 2000 higher than 939 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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