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NCT03230747 · ClinicalTrials.gov registry record · NA
SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
A NA study of Mitral Regurgitation and Mitral Disease, sponsored by Edwards Lifesciences.
- Active
- Registry status
- NA
- Development phase
- 72
- Enrollment target
- 9
- Study locations
NCT03230747: Active NA study of Mitral Regurgitation and Mitral Disease, sponsored by Edwards Lifesciences.
NCT03230747 is a NA study of Mitral Regurgitation and Mitral Disease that is active but no longer recruiting, run by Edwards Lifesciences. The registered enrollment target is 72 participants, below the 1,021-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (93% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03230747, a NA study of Mitral Regurgitation and Mitral Disease, is active but no longer recruiting, sponsored by Edwards Lifesciences.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
- 9
- Study locations
Study Summary
This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System.
Primary Outcome
Defined as meeting all the following: * Alive * Successful access, delivery and retrieval of the delivery systems * Deployment of the devices in the intended position * Freedom from emergency surgery or reintervention related to the device or access procedure
Conditions Studied
Interventions
- DEVICE Edwards SAPIEN M3 System
Study Locations (9)
California
- Cedars-Sinai Medical Center Heart Institute - Los Angeles
- California Pacific Medical Center - San Francisco
Georgia
- Emory University - Atlanta
Illinois
- Evanston/ Northshore University - Evanston
Michigan
- Henry Ford Hospital - Detroit
Minnesota
- Mayo Clinic - Rochester
Utah
- Intermountain Medical Center - Murray
Virginia
- Sentara Cardiovascular Research Institution - Norfolk
British Columbia
- St. Paul's Hospital - Vancouver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2017-09-14 |
| Est. Completion | 2027-08 |
| Phase | NA |
What the registry record for NCT03230747 still lists
NCT03230747 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 1,021-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Mitral Regurgitation appearing as the primary indexed condition, and to 1 intervention - of which Edwards SAPIEN M3 System is the first listed.
NCT03230747 lists 9 locations in 8 states (California, Georgia, Illinois).
Frequently Asked Questions
What is clinical trial NCT03230747 about?
NCT03230747 is a clinical study titled "SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation". This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System.
What is the current status of trial NCT03230747?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 72 participants. The study started on 2017-09-14. Estimated completion is 2027-08.
What conditions does trial NCT03230747 study?
This clinical trial studies the following conditions: Mitral Regurgitation, Mitral Disease.
What interventions are being tested in trial NCT03230747?
The interventions under investigation include: Edwards SAPIEN M3 System (DEVICE).
Who is sponsoring clinical trial NCT03230747?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03230747 being conducted?
This trial has 9 study locations across California, Georgia, Illinois, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mitral Regurgitation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03230747's enrollment target sits among peer trials
72 17th of 26 higher than 10 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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