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NCT04153292 · ClinicalTrials.gov registry record · NA
The ENCIRCLE Trial
A NA study of Mitral Regurgitation and Mitral Valve Insufficiency, sponsored by Edwards Lifesciences.
- Recruiting
- Registry status
- NA
- Development phase
- 900
- Enrollment target
- 20
- Study locations
NCT04153292: Recruiting NA study of Mitral Regurgitation and Mitral Valve Insufficiency, sponsored by Edwards Lifesciences.
NCT04153292 is a NA study of Mitral Regurgitation and Mitral Valve Insufficiency that is actively recruiting participants, run by Edwards Lifesciences. The registered enrollment target is 900 participants, roughly in line with the 990-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target. The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04153292, a NA study of Mitral Regurgitation and Mitral Valve Insufficiency, is actively recruiting participants, sponsored by Edwards Lifesciences.
- RECRUITING
- Registry status
- NA
- Development phase
- 900 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Primary Outcome
Number of subjects with death and/or heart failure rehospitalization
Conditions Studied
Interventions
- DEVICE SAPIEN M3 valve and dock
Study Locations (20)
California
- Scripps Health - La Jolla
- Good Samaritan Hospital - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
- Kaiser Sunset LA - Los Angeles
- Saint Joseph Hospital - Orange
- California Pacific Medical Center - San Francisco
Florida
- Delray Medical Center - Delray Beach
- Cardiac & Vascular Institute Foundation - Gainesville
- Ascension St. Vincent's Hospital - Jacksonville
- Naples Community Hospital - Naples
- Sarasota Memorial Hospital - Sarasota
Arizona
- Banner University Medical Center - Phoenix
- Saint Josephs Hospital Medical Center Dignity Health - Phoenix
- TMC Healthcare - Tucson
Georgia
- Emory University - Atlanta
- Piedmont Healthcare - Atlanta
Illinois
- Rush University Medical Center - Chicago
- Northshore University Health System - Glenview
Alabama
- Heart Center Hospital - Huntsville
Colorado
- UC Health Northern Colorado (Medical Center of the Rockies) - Loveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 900 participants |
| Start Date | 2020-11-12 |
| Est. Completion | 2031-02-28 |
| Phase | NA |
What NCT04153292 shows while recruiting
NCT04153292 is an interventional study that assigns participants to a tested intervention. The registered 900 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 990-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target.
The record links to 2 conditions, with Mitral Regurgitation appearing as the primary indexed condition, and to 1 intervention - of which SAPIEN M3 valve and dock is the first listed.
NCT04153292 names 20 study sites across 7 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT04153292 about?
NCT04153292 is a clinical study titled "The ENCIRCLE Trial". This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be ...
What is the current status of trial NCT04153292?
This trial is currently recruiting. It is a NA study. The enrollment target is 900 participants. The study started on 2020-11-12. Estimated completion is 2031-02-28.
What conditions does trial NCT04153292 study?
This clinical trial studies the following conditions: Mitral Regurgitation, Mitral Valve Insufficiency.
What interventions are being tested in trial NCT04153292?
The interventions under investigation include: SAPIEN M3 valve and dock (DEVICE).
Who is sponsoring clinical trial NCT04153292?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04153292 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04153292's enrollment target sits among peer trials
900 8th of 26 higher than 19 of 26 other Mitral Regurgitation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mitral Regurgitation 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.
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