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Active, not recruiting Not applicable Interventional

Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

ClinicalTrials.gov ID: NCT03706833

Public ClinicalTrials.gov record NCT03706833. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 3:13 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System Compared to Abbott MitraClip in Patients With Mitral Regurgitation

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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)

Study identification

NCT ID
NCT03706833
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Edwards Lifesciences
Industry
Enrollment
1,247 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2018 (Actual)
Primary completion
Jun 30, 2026 (Estimated)
Completion
Jun 30, 2031 (Estimated)
Last update posted
Jul 8, 2026

2018 – 2031

United States locations

U.S. sites
63
U.S. states
25
U.S. cities
53
Facility City State ZIP Site status
Banner University Medical Center Phoenix Arizona 85006 —
TMC Healthcare Tucson Arizona 85712 —
Scripps Memorial Hospital La Jolla La Jolla California 92071 —
Cedars Sinai Medical Center Los Angeles California 90048 —
UC Irvine Orange California 92868 —
Sutter Medical Center-Sacramento Sacramento California 95618 —
Kaiser Permanente San Francisco San Francisco California 94118 —
University of California, San Francisco San Francisco California 94143 —
Stanford University Stanford California 94305 —
Los Robles Hospital and Medical Center Thousand Oaks California 91360 —
Medical Center of the Rockies Loveland Colorado 80538 —
Medstar Washington Hospital Center Washington D.C. District of Columbia 20010 —
The Cardiac and Vascular Institute Research Foundation Gainesville Florida 32605 —
Mount Sinai Miami Beach Florida 33140 —
NCH Rooney Heart Institute Naples Florida 34102 —
AdventHealth Orlando Orlando Florida 32803 —
Piedmont Healthcare Atlanta Georgia 30309 —
Emory University Hospital and Emory University Hospital Midtown Atlanta Georgia 30322 —
Northwestern University Chicago Illinois 60611 —
St. Vincent Heart Center Carmel Indiana 46290 —
University of Iowa Hospitals & Clinics Iowa City Iowa 52242 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Brigham and Woman's Hospital Boston Massachusetts 02115 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
University of Michigan Ann Arbor Michigan 48109 —
Henry Ford Hospital Detroit Michigan 48202 —
Mayo Clinic Rochester Minnesota 55905 —
St.Luke's Hospital of Kansas City Kansas City Missouri 64111 —
Washington University/Barnes Jewish Hospital St Louis Missouri 63110 —
Morristown Medical Center Morristown New Jersey 07960 —
Rutgers-RWJMS New Brunswick New Jersey 08901 —
Albany Medical College Albany New York 12208 —
State University of New York at Buffalo Buffalo New York 14203 —
NYU Langone Hospital - Long Island Mineola New York 11501 —
NYU Langone Health New York New York 10016 —
Columbia University Medical Center/New York Presbyterian Hospital New York New York 10032 —
Lenox Hill Hospital and North Shore University New York New York 10075 —
Rochester General Hospital Rochester New York 14621 —
Montefiore Medical Center The Bronx New York 10467 —
The Christ Hospital Cincinnati Ohio 45219-2906 —
Cleveland Clinic Foundation Cleveland Ohio 44195 —
Oklahoma Cardiovascular Oklahoma City Oklahoma 73120 —
Oklahoma Heart Institute Tulsa Oklahoma 74104 —
Oregon Health & Science University Portland Oregon 97239 —
Hospital of the University of Pennsylvania/Penn Presbyterian Medical Center Philadelphia Pennsylvania 19104 —
Allegheny General Hospital Pittsburgh Pennsylvania 15212 —
Pinnacle Health Cardiovascular Institute/ UPMC Pinnacle Harrisburg Wormleysburg Pennsylvania 17043 —
Lankenau Medical Center Wynnewood Pennsylvania 19096 —
WellSpan York Hospital York Pennsylvania 17405 —
CVA Heart Institute Kingsport Kingsport Tennessee 37660 —
Baptist Memorial Hospital Memphis Memphis Tennessee 38138 —
Centennial Medical Center Nashville Tennessee 37203 —
Saint Thomas Heart at Saint Thomas West Nashville Tennessee 37205 —
Vanderbilt University Medical Center Nashville Tennessee 37232 —
Baylor College of Medicine Houston Texas 77030 —
Houston Methodist Hospital Houston Texas 77030 —
The University of Texas Health Science Center at Houston Houston Texas 77030 —
The Heart Hospital Baylor Plano Plano Texas 75093 —
Intermountain Medical Center Salt Lake City Utah 84107 —
University of Virginia Charlottesville Virginia 22908 —
Sentara Norfolk General Hospital Norfolk Virginia 23507 —
Swedish Medical Center Seattle Washington 98122 —
Aurora St. Luke's Medical Center Milwaukee Wisconsin 53215 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03706833, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 8, 2026 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03706833 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →