CLASP II TR
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
AI Description
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team
- Who can join
- adult, older adult
- Participants
- 1270
- Expected completion
- 2031-12-31
- Funded by
- industry
Conditions studied
Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valve Insufficiency
What is being tested
- DEVICE: Edwards PASCAL System
- DRUG: Optimal Medical Therapy
What it measures
- Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, and Quality of Life improvement (measured by KCCQ score), Comparison of number of participants with composite endpoint events between experimental and active comparator arms, 6 months
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Ascension St. Vincent Heart Center
Carmel, IN
Banner – University Medical Center Phoenix
Phoenix, AZ
Barnes-Jewish Hospital
Saint Louis, MO
Baylor Scott & White The Heart Hospital – Plano
Plano, TX
Baylor St. Luke's Medical Center
Houston, TX
Bethesda North Hospital
Cincinnati, OH
Carilion Roanoke Memorial Hospital
Roanoke, VA
Cedars-Sinai Medical Center
Los Angeles, CA
Cooper University Hospital
Camden, NJ
Corewell Health William Beaumont University Hospital
Royal Oak, MI
Emory University Hospital Midtown
Atlanta, GA
Erlanger
Chattanooga, TN
Froedtert Hospital
Milwaukee, WI
HCA Florida North Florida Hospital
Gainesville, FL
HCA Houston Healthcare Medical Center
Houston, TX
Henry Ford Health (Detroit)
Detroit, MI
Hillcrest Medical Center
Tulsa, OK
Hospital of the University of Pennsylvania
Philadelphia, PA
INTEGRIS Health Heart Hospital at Baptist Medical Center
Oklahoma City, OK
Intermountain Medical Center
Murray, UT
Intermountain St. George Regional Hospital
St George, UT
Kaiser Permanente San Francisco Medical Center
San Francisco, CA
Kaleida Health
Buffalo, NY
Lankenau Medical Center
Wynnewood, PA
Lenox Hill Hospital
New York, NY
Massachusetts General Hospital
Boston, MA
Mayo Clinic (Rochester, Minnesota)
Rochester, MN
Memorial Hermann-Texas Medical Center
Houston, TX
Montefiore Einstein Hospital (Moses Campus)
Bronx, NY
Morristown Medical Center
Morristown, NJ
Mount Sinai Medical Center
Miami Beach, FL
MUSC Health
Charleston, SC
MyMichigan Medical Center Saginaw
Saginaw, MI
Naples Comprehensive Health (NCH)
Naples, FL
NewYork-Presbyterian Hospital
New York, NY
Northwestern Memorial Hospital
Chicago, IL
Ochsner Medical Center – New Orleans
New Orleans, LA
OHSU Hospital
Portland, OR
Oklahoma Heart Hospital (Oklahoma City)
Oklahoma City, OK
Penn Presbyterian Medical Center
Philadelphia, PA
Penn State Health Milton S. Hershey Medical Center
Hershey, PA
Piedmont Atlanta Hospital
Atlanta, GA
Providence St. Patrick Hospital
Missoula, MT
Robert Wood Johnson University Hospital
New Brunswick, NJ
Rochester General Hospital
Rochester, NY
Ronald Reagan UCLA Medical Center
Los Angeles, CA
Saint Joseph Hospital
Denver, CO
Saint Luke’s Hospital of Kansas City
Kansas City, MO
Sanford Medical Center Fargo
Fargo, ND
Sarasota Memorial Hospital
Sarasota, FL
St. Francis Hospital & Heart Center
Roslyn, NY
St. John’s Hospital
Maplewood, MN
Stanford Health Care
Stanford, CA
Swedish Cherry Hill Campus
Seattle, WA
Tallahassee Memorial HealthCare
Tallahassee, FL
The Christ Hospital
Cincinnati, OH
The Johns Hopkins Hospital
Baltimore, MD
The Ohio State University Wexner Medical Center
Columbus, OH
Tucson Medical Center
Tucson, AZ
UCHealth Medical Center of the Rockies
Loveland, CO
UCI Health (Orange)
Orange, CA
UCSF Health
San Francisco, CA
UNC Hospitals
Chapel Hill, NC
University Medical Center
Charlottesville, VA
University of Iowa Health Care
Iowa City, IA
University of Michigan Health System
Ann Arbor, MI
UPMC Harrisburg
Harrisburg, PA
Vanderbilt University Medical Center
Nashville, TN
VCU Medical Center
Richmond, VA
Virginia Mason Medical Center
Seattle, WA
Registry entry updated 2026-09-14
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.