Actively Recruiting
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
Led by Edwards Lifesciences · Updated on 2026-05-08
1270
Participants Needed
79
Research Sites
629 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eighteen (18) years of age or older
- Signs or symptoms of tricuspid regurgitation despite medical therapy
- Severe or greater tricuspid regurgitation
- New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months
- Intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon and local Heart Team
- Ability and willingness to give informed consent, follow protocol, and comply with follow-up visits
You will not qualify if you...
- Tricuspid valve anatomy not evaluable by TTE or TEE
- Tricuspid valve anatomy prevents proper device deployment and function
- Refractory heart failure requiring advanced intervention (e.g., left ventricular assist device or transplant)
- Presence of trans-tricuspid pacemaker or defibrillator leads that interfere with valve function or were implanted in the RV within 90 days before enrollment
- Primary non-degenerative tricuspid disease
- Previous tricuspid valve repair or replacement that would interfere with PASCAL placement
- Untreated significant coronary artery disease requiring revascularization, unstable angina, acute coronary syndrome, or recent myocardial infarction
- Significant intracardiac mass, thrombus, or vegetation
- Deep vein thrombosis or pulmonary embolism within the last 90 days
- Recent stroke
- Active gastrointestinal bleeding
- Infiltrative cardiomyopathy or valvulopathy or significant congenital heart disease
- Need for urgent surgery or planned cardiac surgery within 12 months or percutaneous cardiac procedure within 90 days
- Certain cardiovascular procedures within 30 to 90 days before enrollment
- Severe aortic, mitral, or pulmonic valve stenosis or regurgitation
- Untreated severe symptomatic or asymptomatic carotid stenosis
- Active endocarditis or recent infection requiring antibiotics
- Oxygen dependence or continuous home oxygen requirement
- Pregnant, breastfeeding, or planning pregnancy within the next 12 months
- Life expectancy under 12 months due to other medical conditions
- Participation in another investigational study
- Medical, social, or psychological conditions precluding consent or follow-up
- Vulnerable patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 79 locations
1
Banner University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
Active, Not Recruiting
2
Tucson Medical Center Healthcare
Tucson, Arizona, United States, 85712
Active, Not Recruiting
3
University of California, Irvine
Irvine, California, United States, 92868
Actively Recruiting
4
SCPMG - Kaiser San Diego
La Jolla, California, United States, 92037
Active, Not Recruiting
5
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
6
UCLA Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
7
Kaiser Permanente San Francisco
San Francisco, California, United States, 94118
Active, Not Recruiting
8
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
9
Stanford University
Stanford, California, United States, 94305
Active, Not Recruiting
10
St. Joseph Hospital
Denver, Colorado, United States, 80218
Actively Recruiting
11
Medical Center of the Rockies
Loveland, Colorado, United States, 80538
Active, Not Recruiting
12
The Cardiac and Vascular Institute Research Foundation
Gainesville, Florida, United States, 32605
Actively Recruiting
13
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Actively Recruiting
14
NCH Healthcare System
Naples, Florida, United States, 34102
Actively Recruiting
15
Sarasota Memorial Health Care System
Sarasota, Florida, United States, 34239
Actively Recruiting
16
Tallahassee Research Institute
Tallahassee, Florida, United States, 32308
Active, Not Recruiting
17
Emory University Hospital Midtown / Emory University - St. Joseph's Hospital
Atlanta, Georgia, United States, 30308
Actively Recruiting
18
Piedmont Healthcare, Inc.
Atlanta, Georgia, United States, 30309
Active, Not Recruiting
19
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
20
Ascension St. Vincent Heart Center Cardiovascular Research Institute
Indianapolis, Indiana, United States, 46290
Actively Recruiting
21
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Active, Not Recruiting
22
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
Active, Not Recruiting
23
Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
24
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
25
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
26
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
27
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States, 48073
Actively Recruiting
28
St. Mary's of Ascension Research
Saginaw, Michigan, United States, 48601
Active, Not Recruiting
29
Fairview Health Services
Maplewood, Minnesota, United States, 55109
Active, Not Recruiting
30
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
31
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Actively Recruiting
32
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Active, Not Recruiting
33
Providence St. Patrick Hospital
Missoula, Montana, United States, 59802
Active, Not Recruiting
34
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
35
Cooper Health Systems
Camden, New Jersey, United States, 09103
Actively Recruiting
36
Morristown Medical Center
Morristown, New Jersey, United States, 07962
Actively Recruiting
37
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
38
State University of New York at Buffalo
Buffalo, New York, United States, 14203
Actively Recruiting
39
Columbia University Irving Medical Center/NYPH
New York, New York, United States, 10032
Actively Recruiting
40
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
41
Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset
New York, New York, United States, 10075
Actively Recruiting
42
Rochester General Hospital
Rochester, New York, United States, 14621
Active, Not Recruiting
43
St. Francis Hospital
Roslyn, New York, United States, 11576
Actively Recruiting
44
Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital
The Bronx, New York, United States, 10467
Actively Recruiting
45
University of North Carolina
Chapel Hill, North Carolina, United States, 27517
Actively Recruiting
46
Sanford Medical Center Fargo
Fargo, North Dakota, United States, 58104
Active, Not Recruiting
47
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
48
TriHealth-Bethesda North Hospital
Cincinnati, Ohio, United States, 45242
Active, Not Recruiting
49
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
50
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States, 73112
Active, Not Recruiting
51
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
52
Oklahoma Heart Institute at Hillcrest Medical Center
Tulsa, Oklahoma, United States, 74104
Actively Recruiting
53
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
54
Penn State Hershey
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
55
Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
56
Pinnacle Health Cardiovascular Institute/UPMC Pinnacle
Wormleysburg, Pennsylvania, United States, 17043
Actively Recruiting
57
Lankenau Heart Institute
Wynnewood, Pennsylvania, United States, 19096
Actively Recruiting
58
Medical University of South Carolina
Charleston, South Carolina, United States, 29245
Active, Not Recruiting
59
Erlanger Health System
Chattanooga, Tennessee, United States, 37403
Active, Not Recruiting
60
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Active, Not Recruiting
61
HCA Houston Healthcare Medical Center
Houston, Texas, United States, 77004
Actively Recruiting
62
Baylor College of Medicine St. Luke's Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
63
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
64
UTHealth/Memorial Hermann Hospital
Houston, Texas, United States, 77030
Actively Recruiting
65
Baylor Scott & White - The Heart Hospital - Plano
Plano, Texas, United States, 75093
Actively Recruiting
66
Intermountain Medical Center
Murray, Utah, United States, 84107
Active, Not Recruiting
67
St. George Regional Hospital
St. George, Utah, United States, 84790
Actively Recruiting
68
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Actively Recruiting
69
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Active, Not Recruiting
70
Carilion Medical Center
Roanoke, Virginia, United States, 24014
Actively Recruiting
71
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Actively Recruiting
72
Swedish Medical Center
Seattle, Washington, United States, 98122
Active, Not Recruiting
73
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
74
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Active, Not Recruiting
75
Hamilton Health Services
Hamilton, Ontario, Canada, L8L 2X2
Active, Not Recruiting
76
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4Q7
Active, Not Recruiting
77
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Active, Not Recruiting
78
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Active, Not Recruiting
79
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec, Canada, G1V 4G5
Active, Not Recruiting
Research Team
E
Edwards TMTT Clinical Affairs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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