What this study is
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
What's being tested
- Edwards PASCAL System
Intervention · DEVICE
Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy
- Optimal Medical Therapy
Intervention · DRUG
Optimal Medical Therapy alone in patients with tricuspid regurgitation
- Edwards PASCAL System
Intervention · DEVICE
Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT
- Edwards PASCAL System
Intervention · DEVICE
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
Study details
- 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
- Sponsor
- Edwards Lifesciences
- Conditions
- Tricuspid Regurgitation · Tricuspid Valve Insufficiency · Tricuspid Valve Disease
- Enrolling
- 1,270 people
- Starts
- 2019-12-11
- Est. completion
- 2031-12-31
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Eighteen (18) years of age or older
- Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.
- Severe or greater tricuspid regurgitation
- New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months
- Patient is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon with concurrence by the local Heart Team
- Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements
You can't join if
- Tricuspid valve anatomy not evaluable by TTE or TEE
- Tricuspid valve anatomy precludes proper device deployment and function
- Patient with refractory heart failure requiring, advanced intervention (i.e. patient has or will need left ventricular assist device, or transplantation) (ACC/AHA Stage D heart failure)
- Presence of trans-tricuspid pacemaker or defibrillator leads which meet one of the following:; Would prevent proper TR reduction due to interaction of the lead with the leaflets; Were implanted in the RV within the last 90 days prior to the point of enrollment
- Primary non-degenerative tricuspid disease
- Previous tricuspid valve repair or replacement that would interfere with placement of PASCAL
- Clinically significant, untreated coronary artery disease requiring revascularization, unstable angina, evidence of acute coronary syndrome, recent myocardial infarction
- Significant intra-cardiac mass, thrombus, or vegetation per echo core lab assessment
- Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 90 days
- Recent Stroke
- Active gastrointestinal (GI) bleeding
- Presence of infiltrative cardiomyopathy or valvulopathy (including carcinoid, amyloidosis, sarcoidosis, hemochromatosis) or significant congenital heart disease, including but not limited to atrial septal defect, RV dysplasia, and arrhythmogenic RV
- Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous cardiac procedure within the next 90 days
- Any of the following cardiovascular procedures:; Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days prior to the point of enrollment; Carotid surgery within 30 days prior to the point of enrollment; Direct current cardioversion within the last 30 days prior to the point of enrollment; Leadless RV pacemaker implant within the last 30 days prior to the point of enrollment; Cardiac surgery within 90 days prior to the point of enrollment
- Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
- Known history of untreated severe symptomatic carotid stenosis or asymptomatic carotid stenosis
- Active endocarditis within the last 90 days or infection requiring antibiotic therapy within the last 14 days
- Patient is oxygen-dependent or requires continuous home oxygen
- Pregnant, breastfeeding, or planning pregnancy within the next 12 months (365 days)
- Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
- Patient is currently participating in another investigational biologic, drug, or device clinical study
- Patient has other medical, social, or psychological conditions that preclude appropriate consent and follow-up, or the patient is under guardianship
- Any patient considered to be vulnerable
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (79)
45 openUniversity of California, Irvine
Irvine, California, United States
- Antonio Frangieh, MD · Principal investigator
RecruitingUniversity of California, San Francisco
San Francisco, California, United States
- Sammy Elmariah, MD · Principal investigator
RecruitingSt. Joseph Hospital
Denver, Colorado, United States
- Jake Chanin, MD · Principal investigator
RecruitingThe Cardiac and Vascular Institute Research Foundation
Gainesville, Florida, United States
- Charles Klodell, MD · Principal investigator
- Ilie Barb, MD · Principal investigator
RecruitingMount Sinai Medical Center
Miami Beach, Florida, United States
- Nirat Beohar, MD · Principal investigator
- Steve Xydas, MD · Principal investigator
RecruitingNCH Healthcare System
Naples, Florida, United States
- Robert Cubeddu, MD · Principal investigator
RecruitingSarasota Memorial Health Care System
Sarasota, Florida, United States
- Ricardo A. Yaryura, MD · Principal investigator
RecruitingEmory University Hospital Midtown / Emory University - St. Joseph's Hospital
Atlanta, Georgia, United States
- Adam Greenbaum, MD · Principal investigator
RecruitingNorthwestern University
Chicago, Illinois, United States
- Charles Davidson, MD · Principal investigator
RecruitingAscension St. Vincent Heart Center Cardiovascular Research Institute
Indianapolis, Indiana, United States
- James Hermiller, MD · Principal investigator
RecruitingJohns Hopkins
Baltimore, Maryland, United States
- Rani Hasan, MD · Principal investigator
RecruitingMassachusetts General Hospital
Boston, Massachusetts, United States
- Nilay Patel, MD · Principal investigator
- Ignacio Inglessis, MD · Principal investigator
RecruitingUniversity of Michigan
Ann Arbor, Michigan, United States
- Stanley Chetcuti, MD · Principal investigator
RecruitingHenry Ford Hospital
Detroit, Michigan, United States
- Brian O' Neill, MD · Principal investigator
RecruitingMayo Clinic
Rochester, Minnesota, United States
- Mackram Eleid, MD · Principal investigator
RecruitingSaint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
- Adnan Chhatriwalla, MD · Principal investigator
RecruitingDartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
- Michael Young, MD · Principal investigator
RecruitingCooper Health Systems
Camden, New Jersey, United States
- Sajjad Sabir, MD · Principal investigator
RecruitingMorristown Medical Center
Morristown, New Jersey, United States
- Gennaro Giustino, MD · Principal investigator
RecruitingRutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
- Mark Russo, MD · Principal investigator
RecruitingState University of New York at Buffalo
Buffalo, New York, United States
- Vijay Iyer, MD, PhD · Principal investigator
RecruitingColumbia University Irving Medical Center/NYPH
New York, New York, United States
- Michael Brener, MD · Principal investigator
RecruitingWeill Cornell Medicine
New York, New York, United States
- Shmuel Chen, MD · Principal investigator
RecruitingLenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset
New York, New York, United States
- Mei Chau, MD · Principal investigator
- Bruce Rutkin, MD · Principal investigator
RecruitingSt. Francis Hospital
Roslyn, New York, United States
- George A. Petrossian, MD · Principal investigator
- Newell B. Robinson, MD · Principal investigator
RecruitingMontefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital
The Bronx, New York, United States
- Mohamed A. Latib, MD · Principal investigator
RecruitingUniversity of North Carolina
Chapel Hill, North Carolina, United States
- John Vavalle, MD · Principal investigator
RecruitingThe Christ Hospital
Cincinnati, Ohio, United States
- Santiago Garcia, MD · Principal investigator
RecruitingThe Ohio State University
Columbus, Ohio, United States
- Konstantinos Boudoulas, MD · Principal investigator
- Scott Lilly, MD · Principal investigator
RecruitingOklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, United States
- Mohammad Ghani, MD · Principal investigator
RecruitingOklahoma Heart Institute at Hillcrest Medical Center
Tulsa, Oklahoma, United States
- Kamran Muhammad, MD · Principal investigator
RecruitingOregon Health & Science University
Portland, Oregon, United States
- Firas Zahr, MD · Principal investigator
- Scott Chadderdon, MD · Principal investigator
RecruitingPenn State Hershey
Hershey, Pennsylvania, United States
- Mark Kozak, MD · Principal investigator
RecruitingPinnacle Health Cardiovascular Institute/UPMC Pinnacle
Wormleysburg, Pennsylvania, United States
- Mubashir Mumtaz, MD · Principal investigator
RecruitingLankenau Heart Institute
Wynnewood, Pennsylvania, United States
- William Gray, MD · Principal investigator
RecruitingHCA Houston Healthcare Medical Center
Houston, Texas, United States
- Pranav Loyalka, MD · Principal investigator
RecruitingBaylor College of Medicine St. Luke's Medical Center
Houston, Texas, United States
- Guilherme Silva, MD · Principal investigator
RecruitingThe University of Texas Health Science Center at Houston
Houston, Texas, United States
- Abhijeet Dhoble, MD · Principal investigator
- Richard Smalling, MD · Principal investigator
RecruitingUTHealth/Memorial Hermann Hospital
Houston, Texas, United States
- Biswajit Kar, MD · Principal investigator
RecruitingBaylor Scott & White - The Heart Hospital - Plano
Plano, Texas, United States
- Molly Szerlip, MD · Principal investigator
RecruitingSt. George Regional Hospital
St. George, Utah, United States
- Blake Gardner, MD · Principal investigator
RecruitingUniversity of Virginia Health System
Charlottesville, Virginia, United States
- John Saxon, MD · Principal investigator
RecruitingCarilion Medical Center
Roanoke, Virginia, United States
- Jason Foerst, MD · Principal investigator
RecruitingVirginia Mason Medical Center
Seattle, Washington, United States
- Ming Zhang, MD · Principal investigator
RecruitingMedical College of Wisconsin
Milwaukee, Wisconsin, United States
- Jeremiah Depta, MD · Principal investigator
RecruitingBanner University Medical Center Phoenix
Phoenix, Arizona, United States
Active, not recruitingTucson Medical Center Healthcare
Tucson, Arizona, United States
Active, not recruitingSCPMG - Kaiser San Diego
La Jolla, California, United States
Active, not recruitingCedars Sinai Medical Center
Los Angeles, California, United States
Active, not recruitingUCLA Medical Center
Los Angeles, California, United States
Active, not recruitingKaiser Permanente San Francisco
San Francisco, California, United States
Active, not recruitingStanford University
Stanford, California, United States
Active, not recruitingMedical Center of the Rockies
Loveland, Colorado, United States
Active, not recruitingTallahassee Research Institute
Tallahassee, Florida, United States
Active, not recruitingPiedmont Healthcare, Inc.
Atlanta, Georgia, United States
Active, not recruitingUniversity of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Active, not recruitingOchsner Medical Center
New Orleans, Louisiana, United States
Active, not recruitingWilliam Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States
Active, not recruitingSt. Mary's of Ascension Research
Saginaw, Michigan, United States
Active, not recruitingFairview Health Services
Maplewood, Minnesota, United States
Active, not recruitingWashington University School of Medicine
St Louis, Missouri, United States
Active, not recruitingProvidence St. Patrick Hospital
Missoula, Montana, United States
Active, not recruitingRochester General Hospital
Rochester, New York, United States
Active, not recruitingSanford Medical Center Fargo
Fargo, North Dakota, United States
Active, not recruitingTriHealth-Bethesda North Hospital
Cincinnati, Ohio, United States
Active, not recruitingIntegris Baptist Medical Center
Oklahoma City, Oklahoma, United States
Active, not recruitingPennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Active, not recruitingMedical University of South Carolina
Charleston, South Carolina, United States
Active, not recruitingErlanger Health System
Chattanooga, Tennessee, United States
Active, not recruitingVanderbilt University Medical Center
Nashville, Tennessee, United States
Active, not recruitingIntermountain Medical Center
Murray, Utah, United States
Active, not recruitingVirginia Commonwealth University
Richmond, Virginia, United States
Active, not recruitingSwedish Medical Center
Seattle, Washington, United States
Active, not recruiting
6 sites outside the US
St. Paul's Hospital
Vancouver, British Columbia, Canada
Active, not recruitingHamilton Health Services
Hamilton, Ontario, Canada
Active, not recruitingUniversity of Ottawa Heart Institute
Ottawa, Ontario, Canada
Active, not recruitingSunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Active, not recruitingSt. Michael's Hospital
Toronto, Ontario, Canada
Active, not recruitingInstitut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec, Canada
Active, not recruiting
Study team
Sponsor
Edwards Lifesciences
Study ID 2019-07
Principal investigator
Martin B. Leon, MD
Columbia University
Principal investigator
Michael J. Mack, MD
Baylor Scott and White Health
Principal investigator
Charles Davidson, MD
Northwestern University
Study chair
Allen Anderson, MD
The University of Texas Health Science Center at San Antonio
Study chair
Gorav Ailawadi, MD
University of Michigan
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.