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Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
NCT03706833 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,247 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edwards Lifesciences, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03706833 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03706833?
The interventions under investigation include: Edwards PASCAL System (DEVICE), Abbott Mitraclip System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03706833?
This trial is sponsored by Edwards Lifesciences, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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