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NCT02370511 · ClinicalTrials.gov registry record · NA
Mitral Implantation of TRAnscatheter vaLves
A NA study, sponsored by Mayra Guerrero.
- Completed
- Registry status
- NA
- Development phase
- 91
- Enrollment target
NCT02370511: Completed NA study, sponsored by Mayra Guerrero.
NCT02370511 is a NA study that has completed, run by Mayra Guerrero. The registered enrollment target is 91 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
NCT02370511, a NA study, has completed, sponsored by Mayra Guerrero.
- COMPLETED
- Registry status
- NA
- Development phase
- 91 participants
- Enrollment target
Study Summary
The purpose of this trial is to establish the safety and feasibility of the Edwards SAPIEN XT™and SAPIEN 3™ device and delivery systems in patients with severe symptomatic calcific mitral valve disease with severe mitral annular calcification who are not candidates for standard mitral valve surgery.
Primary Outcome
Number of subject to achieve technical success (at exit from cath lab) is defined as: * Successful vascular delivery and retrieval of transcatheter valve delivery system * Deployment of single valve * Correct position of transcatheter valve * Adequate performance of prosthesis (MVA \> 1.5 cm2) without residual MR grade ≥2 (+) * No need for additional surgery or re-intervention * Patient leaves cath lab alive
Interventions
- DEVICE Transcatheter Mitral Valve Replacement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2015-02-25 |
| Est. Completion | 2018-12 |
| Phase | NA |
What the finished NCT02370511 record still lists
NCT02370511 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 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 Transcatheter Mitral Valve Replacement is the first listed.
NCT02370511 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02370511 about?
NCT02370511 is a clinical study titled "Mitral Implantation of TRAnscatheter vaLves". The purpose of this trial is to establish the safety and feasibility of the Edwards SAPIEN XT™and SAPIEN 3™ device and delivery systems in patients with severe symptomatic calcific mitral valve disease with severe mitral annular calcification who are not candidates for standard mitral valve surgery.
What is the current status of trial NCT02370511?
This trial is currently completed. It is a NA study. The enrollment target is 91 participants. The study started on 2015-02-25. Estimated completion is 2018-12.
What interventions are being tested in trial NCT02370511?
The interventions under investigation include: Transcatheter Mitral Valve Replacement (DEVICE).
Who is sponsoring clinical trial NCT02370511?
This trial is sponsored by Mayra Guerrero, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02370511's enrollment target sits among peer trials
91 939th of 2000 higher than 1,060 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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