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NCT03706833 · ClinicalTrials.gov registry record · NA
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
A NA study of Mitral Regurgitation and Functional Mitral Regurgitation, sponsored by Edwards Lifesciences.
- Active
- Registry status
- NA
- Development phase
- 1,247
- Enrollment target
- 20
- Study locations
NCT03706833 is a NA study of Mitral Regurgitation and Functional Mitral Regurgitation that is active but no longer recruiting, run by Edwards Lifesciences. The registered enrollment target is 1,247 participants, above the 976-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (28% higher). The trial reports 20 study locations across 6 states.
The verdict
NCT03706833, a NA study of Mitral Regurgitation and Functional Mitral Regurgitation, is active but no longer recruiting, sponsored by Edwards Lifesciences.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 1,247 participants
- Enrollment target
- 20
- Study locations
Study Summary
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)
Conditions Studied
Interventions
- DEVICE Edwards PASCAL System
- DEVICE Abbott Mitraclip System
Study Locations (20)
California
- Scripps Memorial Hospital La Jolla - La Jolla
- Cedars Sinai Medical Center - Los Angeles
- UC Irvine - Orange
- Sutter Medical Center-Sacramento - Sacramento
- Sutter Bay Area - San Francisco
- Kaiser Permanente San Francisco - San Francisco
- University of California, San Francisco - San Francisco
- Stanford University - Stanford
- Los Robles Hospital and Medical Center - Thousand Oaks
Florida
- The Cardiac and Vascular Institute Research Foundation - Gainesville
- Mount Sinai - Miami Beach
- NCH Rooney Heart Institute - Naples
- AdventHealth Orlando - Orlando
Arizona
- Banner University Medical Center - Phoenix
- Abrazo Arizona Heart Hospital - Phoenix
- TMC Healthcare - Tucson
Georgia
- Piedmont Healthcare - Atlanta
- Emory University Hospital and Emory University Hospital Midtown - Atlanta
Colorado
- Medical Center of the Rockies - Loveland
District of Columbia
- Medstar Washington Hospital Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,247 participants |
| Start Date | 2018-11-30 |
| Est. Completion | 2031-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03706833
The ClinicalTrials.gov registry entry for NCT03706833 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 1,247 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 976-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (28% higher). The listed sponsor is Edwards Lifesciences, which has 57 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Mitral Regurgitation appearing as the primary indexed condition, and to 2 interventions - of which Edwards PASCAL System is the first listed.
NCT03706833 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT03706833 about?
NCT03706833 is a clinical study titled "Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial". To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitati...
What is the current status of trial NCT03706833?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,247 participants. The study started on 2018-11-30. Estimated completion is 2031-06-30.
What conditions does trial NCT03706833 study?
This clinical trial studies the following conditions: Mitral Regurgitation, Functional Mitral Regurgitation, Mitral Insufficiency, Degenerative Mitral Valve Disease.
What interventions are being tested in trial NCT03706833?
The interventions under investigation include: Edwards PASCAL System (DEVICE), Abbott Mitraclip System (DEVICE).
Who is sponsoring clinical trial NCT03706833?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03706833 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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