New heart valve fix could help High-Risk patients avoid major surgery

NCT ID NCT04097145

Recruiting now Disease control Sponsor: Edwards Lifesciences Source: ClinicalTrials.gov ↗

Summary

This study is testing a new device called the PASCAL system, which is designed to repair a leaky tricuspid heart valve without open-heart surgery. It will compare the device plus standard medical care against medical care alone in about 870 patients who have severe symptoms and are considered too high-risk for traditional valve surgery. The main goal is to see if the device is safe and can reduce deaths, hospital stays, and improve patients' quality of life.

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes NO responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Ascension St. Vincent Heart Center Cardiovascular Research Institute
RECRUITING

Indianapolis, Indiana, 46290, United States

Contact
Banner University Medical Center Phoenix
ACTIVE_NOT_RECRUITING

Phoenix, Arizona, 85006, United States
Baylor College of Medicine St. Luke's Medical Center
RECRUITING

Houston, Texas, 77030, United States

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Baylor Scott & White - The Heart Hospital - Plano
RECRUITING

Plano, Texas, 75093, United States

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Carilion Medical Center
RECRUITING

Roanoke, Virginia, 24014, United States

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Cedars Sinai Medical Center
RECRUITING

Los Angeles, California, 90048, United States

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Columbia University Irving Medical Center/NYPH
RECRUITING

New York, New York, 10032, United States

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Cooper Health Systems
RECRUITING

Camden, New Jersey, 09103, United States

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Dartmouth-Hitchcock Medical Center
RECRUITING

Lebanon, New Hampshire, 03756, United States

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Emory University Hospital Midtown / Emory University - St. Joseph's Hospital
RECRUITING

Atlanta, Georgia, 30308, United States

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Erlanger Health System
ACTIVE_NOT_RECRUITING

Chattanooga, Tennessee, 37403, United States
Fairview Health Services
ACTIVE_NOT_RECRUITING

Maplewood, Minnesota, 55109, United States
HCA Houston Healthcare Medical Center
RECRUITING

Houston, Texas, 77004, United States

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Hamilton Health Services
ACTIVE_NOT_RECRUITING

Hamilton, Ontario, L8L 2X2, Canada
Henry Ford Hospital
RECRUITING

Detroit, Michigan, 48202, United States

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Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
ACTIVE_NOT_RECRUITING

Québec, Quebec, G1V 4G5, Canada
Integris Baptist Medical Center
ACTIVE_NOT_RECRUITING

Oklahoma City, Oklahoma, 73112, United States
Intermountain Medical Center
ACTIVE_NOT_RECRUITING

Murray, Utah, 84107, United States
Johns Hopkins
RECRUITING

Baltimore, Maryland, 21287, United States

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Kaiser Permanente San Francisco
ACTIVE_NOT_RECRUITING

San Francisco, California, 94118, United States
Lankenau Heart Institute
RECRUITING

Wynnewood, Pennsylvania, 19096, United States

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Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset
RECRUITING

New York, New York, 10075, United States

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Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States

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Mayo Clinic
RECRUITING

Rochester, Minnesota, 55905, United States

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Medical Center of the Rockies
ACTIVE_NOT_RECRUITING

Loveland, Colorado, 80538, United States
Medical College of Wisconsin
RECRUITING

Milwaukee, Wisconsin, 53226, United States

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Medical University of South Carolina
ACTIVE_NOT_RECRUITING

Charleston, South Carolina, 29245, United States
Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital
RECRUITING

The Bronx, New York, 10467, United States

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Morristown Medical Center
RECRUITING

Morristown, New Jersey, 07962, United States

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Mount Sinai Medical Center
RECRUITING

Miami Beach, Florida, 33140, United States

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NCH Healthcare System
RECRUITING

Naples, Florida, 34102, United States

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Northwestern University
RECRUITING

Chicago, Illinois, 60611, United States

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Ochsner Medical Center
ACTIVE_NOT_RECRUITING

New Orleans, Louisiana, 70121, United States
Oklahoma Cardiovascular Research Group
RECRUITING

Oklahoma City, Oklahoma, 73120, United States

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Oklahoma Heart Institute at Hillcrest Medical Center
RECRUITING

Tulsa, Oklahoma, 74104, United States

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Oregon Health & Science University
RECRUITING

Portland, Oregon, 97239, United States

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Penn State Hershey
RECRUITING

Hershey, Pennsylvania, 17033, United States

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Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania
RECRUITING

Philadelphia, Pennsylvania, 19104, United States

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Contact
Piedmont Healthcare, Inc.
ACTIVE_NOT_RECRUITING

Atlanta, Georgia, 30309, United States
Pinnacle Health Cardiovascular Institute/UPMC Pinnacle
RECRUITING

Wormleysburg, Pennsylvania, 17043, United States

Contact

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Providence St. Patrick Hospital
ACTIVE_NOT_RECRUITING

Missoula, Montana, 59802, United States
Rochester General Hospital
ACTIVE_NOT_RECRUITING

Rochester, New York, 14621, United States
Rutgers Robert Wood Johnson Medical School
RECRUITING

New Brunswick, New Jersey, 08901, United States

Contact
SCPMG - Kaiser San Diego
ACTIVE_NOT_RECRUITING

La Jolla, California, 92037, United States
Saint Luke's Hospital of Kansas City
RECRUITING

Kansas City, Missouri, 64111, United States

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Sanford Medical Center Fargo
ACTIVE_NOT_RECRUITING

Fargo, North Dakota, 58104, United States
Sarasota Memorial Health Care System
RECRUITING

Sarasota, Florida, 34239, United States

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St. Francis Hospital
RECRUITING

Roslyn, New York, 11576, United States

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St. George Regional Hospital
RECRUITING

St. George, Utah, 84790, United States

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St. Joseph Hospital
RECRUITING

Denver, Colorado, 80218, United States

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St. Mary's of Ascension Research
ACTIVE_NOT_RECRUITING

Saginaw, Michigan, 48601, United States
St. Michael's Hospital
ACTIVE_NOT_RECRUITING

Toronto, Ontario, M5B 1W8, Canada
St. Paul's Hospital
ACTIVE_NOT_RECRUITING

Vancouver, British Columbia, V6Z 1Y6, Canada
Stanford University
ACTIVE_NOT_RECRUITING

Stanford, California, 94305, United States
State University of New York at Buffalo
RECRUITING

Buffalo, New York, 14203, United States

Contact
Sunnybrook Health Sciences Centre
ACTIVE_NOT_RECRUITING

Toronto, Ontario, M4N 3M5, Canada
Swedish Medical Center
ACTIVE_NOT_RECRUITING

Seattle, Washington, 98122, United States
Tallahassee Research Institute
RECRUITING

Tallahassee, Florida, 32308, United States

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The Cardiac and Vascular Institute Research Foundation
RECRUITING

Gainesville, Florida, 32605, United States

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The Christ Hospital
RECRUITING

Cincinnati, Ohio, 45219, United States

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The Ohio State University
RECRUITING

Columbus, Ohio, 43210, United States

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Contact
The University of Texas Health Science Center at Houston
RECRUITING

Houston, Texas, 77030, United States

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Contact
TriHealth-Bethesda North Hospital
ACTIVE_NOT_RECRUITING

Cincinnati, Ohio, 45242, United States
Tucson Medical Center Healthcare
ACTIVE_NOT_RECRUITING

Tucson, Arizona, 85712, United States
UCLA Medical Center
RECRUITING

Los Angeles, California, 90095, United States

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UTHealth/Memorial Hermann Hospital
RECRUITING

Houston, Texas, 77030, United States

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University of California, Irvine
RECRUITING

Irvine, California, 92868, United States

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University of California, San Francisco
RECRUITING

San Francisco, California, 94143, United States

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University of Iowa Hospitals & Clinics
ACTIVE_NOT_RECRUITING

Iowa City, Iowa, 52242, United States
University of Michigan
RECRUITING

Ann Arbor, Michigan, 48109, United States

Contact
University of North Carolina
RECRUITING

Chapel Hill, North Carolina, 27517, United States

Contact
University of Ottawa Heart Institute
ACTIVE_NOT_RECRUITING

Ottawa, Ontario, K1Y 4Q7, Canada
University of Virginia Health System
RECRUITING

Charlottesville, Virginia, 22908, United States

Contact
Vanderbilt University Medical Center
ACTIVE_NOT_RECRUITING

Nashville, Tennessee, 37212, United States
Virginia Commonwealth University
ACTIVE_NOT_RECRUITING

Richmond, Virginia, 23298, United States
Virginia Mason Medical Center
RECRUITING

Seattle, Washington, 98101, United States

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Washington University School of Medicine
RECRUITING

St Louis, Missouri, 63110, United States

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Weill Cornell Medicine
RECRUITING

New York, New York, 10065, United States

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William Beaumont Hospital - Royal Oak
RECRUITING

Royal Oak, Michigan, 48073, United States

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Conditions

Explore the condition pages connected to this study.

TRICUSPID REGURGITATION TRICUSPID VALVE DISEASE TRICUSPID VALVE INSUFFICIENCY