Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

ClinicalTrials.gov ID: NCT04097145

Public ClinicalTrials.gov record NCT04097145. 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.

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ClinicalTrials.gov public records Last synced May 10, 2026, 4:00 PM EDT

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

Official title

A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation

Study identification

NCT ID: NCT04097145
Recruitment status: Recruiting
Study type: Interventional
Phase: Not applicable
Lead sponsor: Edwards Lifesciences; Industry
Enrollment: 1,270 participants

Conditions and interventions

Conditions

Interventions

Edwards PASCAL System Device
Optimal Medical Therapy Drug

Device · Drug

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: Dec 10, 2019
Primary completion: Dec 30, 2027
Completion: Dec 30, 2031
Last update posted: May 7, 2026

2019 – 2031

United States locations

U.S. sites: 73
U.S. states: 31
U.S. cities: 62

Facility	City	State	ZIP	Site status
Banner University Medical Center Phoenix	Phoenix	Arizona	85006	Active, not recruiting
Tucson Medical Center Healthcare	Tucson	Arizona	85712	Active, not recruiting
University of California, Irvine	Irvine	California	92868	Recruiting
SCPMG - Kaiser San Diego	La Jolla	California	92037	Active, not recruiting
Cedars Sinai Medical Center	Los Angeles	California	90048	Recruiting
UCLA Medical Center	Los Angeles	California	90095	Recruiting
Kaiser Permanente San Francisco	San Francisco	California	94118	Active, not recruiting
University of California, San Francisco	San Francisco	California	94143	Recruiting
Stanford University	Stanford	California	94305	Active, not recruiting
St. Joseph Hospital	Denver	Colorado	80218	Recruiting
Medical Center of the Rockies	Loveland	Colorado	80538	Active, not recruiting
The Cardiac and Vascular Institute Research Foundation	Gainesville	Florida	32605	Recruiting
Mount Sinai Medical Center	Miami Beach	Florida	33140	Recruiting
NCH Healthcare System	Naples	Florida	34102	Recruiting
Sarasota Memorial Health Care System	Sarasota	Florida	34239	Recruiting
Tallahassee Research Institute	Tallahassee	Florida	32308	Active, not recruiting
Emory University Hospital Midtown / Emory University - St. Joseph's Hospital	Atlanta	Georgia	30308	Recruiting
Piedmont Healthcare, Inc.	Atlanta	Georgia	30309	Active, not recruiting
Northwestern University	Chicago	Illinois	60611	Recruiting
Ascension St. Vincent Heart Center Cardiovascular Research Institute	Indianapolis	Indiana	46290	Recruiting
University of Iowa Hospitals & Clinics	Iowa City	Iowa	52242	Active, not recruiting
Ochsner Medical Center	New Orleans	Louisiana	70121	Active, not recruiting
Johns Hopkins	Baltimore	Maryland	21287	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	02114	Recruiting
University of Michigan	Ann Arbor	Michigan	48109	Recruiting
Henry Ford Hospital	Detroit	Michigan	48202	Recruiting
William Beaumont Hospital - Royal Oak	Royal Oak	Michigan	48073	Recruiting
St. Mary's of Ascension Research	Saginaw	Michigan	48601	Active, not recruiting
Fairview Health Services	Maplewood	Minnesota	55109	Active, not recruiting
Mayo Clinic	Rochester	Minnesota	55905	Recruiting
Saint Luke's Hospital of Kansas City	Kansas City	Missouri	64111	Recruiting
Washington University School of Medicine	St Louis	Missouri	63110	Active, not recruiting
Providence St. Patrick Hospital	Missoula	Montana	59802	Active, not recruiting
Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	03756	Recruiting
Cooper Health Systems	Camden	New Jersey	09103	Recruiting
Morristown Medical Center	Morristown	New Jersey	07962	Recruiting
Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey	08901	Recruiting
State University of New York at Buffalo	Buffalo	New York	14203	Recruiting
Columbia University Irving Medical Center/NYPH	New York	New York	10032	Recruiting
Weill Cornell Medicine	New York	New York	10065	Recruiting
Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset	New York	New York	10075	Recruiting
Rochester General Hospital	Rochester	New York	14621	Active, not recruiting
St. Francis Hospital	Roslyn	New York	11576	Recruiting
Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital	The Bronx	New York	10467	Recruiting
University of North Carolina	Chapel Hill	North Carolina	27517	Recruiting
Sanford Medical Center Fargo	Fargo	North Dakota	58104	Active, not recruiting
The Christ Hospital	Cincinnati	Ohio	45219	Recruiting
TriHealth-Bethesda North Hospital	Cincinnati	Ohio	45242	Active, not recruiting
The Ohio State University	Columbus	Ohio	43210	Recruiting
Integris Baptist Medical Center	Oklahoma City	Oklahoma	73112	Active, not recruiting
Oklahoma Cardiovascular Research Group	Oklahoma City	Oklahoma	73120	Recruiting
Oklahoma Heart Institute at Hillcrest Medical Center	Tulsa	Oklahoma	74104	Recruiting
Oregon Health & Science University	Portland	Oregon	97239	Recruiting
Penn State Hershey	Hershey	Pennsylvania	17033	Recruiting
Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	19104	Recruiting
Pinnacle Health Cardiovascular Institute/UPMC Pinnacle	Wormleysburg	Pennsylvania	17043	Recruiting
Lankenau Heart Institute	Wynnewood	Pennsylvania	19096	Recruiting
Medical University of South Carolina	Charleston	South Carolina	29245	Active, not recruiting
Erlanger Health System	Chattanooga	Tennessee	37403	Active, not recruiting
Vanderbilt University Medical Center	Nashville	Tennessee	37212	Active, not recruiting
HCA Houston Healthcare Medical Center	Houston	Texas	77004	Recruiting
Baylor College of Medicine St. Luke's Medical Center	Houston	Texas	77030	Recruiting
The University of Texas Health Science Center at Houston	Houston	Texas	77030	Recruiting
UTHealth/Memorial Hermann Hospital	Houston	Texas	77030	Recruiting
Baylor Scott & White - The Heart Hospital - Plano	Plano	Texas	75093	Recruiting
Intermountain Medical Center	Murray	Utah	84107	Active, not recruiting
St. George Regional Hospital	St. George	Utah	84790	Recruiting
University of Virginia Health System	Charlottesville	Virginia	22908	Recruiting
Virginia Commonwealth University	Richmond	Virginia	23298	Active, not recruiting
Carilion Medical Center	Roanoke	Virginia	24014	Recruiting
Virginia Mason Medical Center	Seattle	Washington	98101	Recruiting
Swedish Medical Center	Seattle	Washington	98122	Active, not recruiting
Medical College of Wisconsin	Milwaukee	Wisconsin	53226	Recruiting

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 6 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04097145, 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 May 7, 2026 · Synced May 10, 2026

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The complete protocol, eligibility criteria, and contact information for NCT04097145 live on ClinicalTrials.gov.

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