Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
- Conditions
- Tricuspid Valve InsufficiencyTricuspid RegurgitationTricuspid Valve Disease
- Interventions
- Device: Edwards PASCAL SystemDrug: Optimal Medical Therapy
- Registration Number
- NCT04097145
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
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
- Detailed Description
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. Patients will be seen for follow-up visits at discharge, 30 days, 3 months, 6 months, and annually through 5 years.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 870
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Edwards PASCAL System & OMT Edwards PASCAL System Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation Optimal Medical Therapy (OMT) Optimal Medical Therapy Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation Single-Arm Registry Edwards PASCAL System Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization Continued Access Study Edwards PASCAL System Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
- Primary Outcome Measures
Name Time Method 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) 12 months Comparison of number of participants with composite endpoint events between experimental and active comparator arms
- Secondary Outcome Measures
Name Time Method 1 Grade Reduction in TR Severity 6, 12 months Total number of participants with at least 1 grade reduction in TR severity
Quality of Life (QOL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) 3, 6, and 12 months Change in KCCQ score from baseline
All Cause Mortality 12 months, 24 months Total number of deaths from any cause
Death and Heart Failure Hospitalizations 12 months Total number of deaths and hospital admissions due to heart failure
All-cause Hospitalization 12 months Total number of hospitalizations due to any cause
Right ventricular end-diastolic diameter (RVEDD mid) 12 months Change in right ventricular end-diastolic diameter (RVEDD mid)
Major Adverse Events (MAEs) 30 days Overall rate of Major Adverse Events (MAEs)
Reduction in TR grade Intraprocedural post-implantation Reduction in TR severity as assessed by TEE pre- and post-implantation
All-Cause Mortality 12 months, annually through 5 years Total number of deaths from any cause
Heart failure hospitalizations 12 months, annually through 5 years Total number of hospital admissions due to heart failure
Non-elective tricuspid valve re-intervenitions (percutaneous or surgical) 12 months, annually through 5 years Total number of non-elective tricuspid valve re-interventions
Durable RVAD implantation or heart transplant 12 months, annually through 5 years Total number of patients requiring RVAD impantantion or heart transplant
Need for paracentesis 12 months, annually through 5 years Total nunber of patients who required paracentesis
All cause mortality or the first heart failure hospitalization for patients with massive or torrential TR at baseline 12, 24 months Time to death or first heart failure hospitalization
Trial Locations
- Locations (79)
Banner University Medical Center Phoenix
🇺🇸Phoenix, Arizona, United States
Tucson Medical Center Healthcare
🇺🇸Tucson, Arizona, United States
University of California, Irvine
🇺🇸Irvine, California, United States
SCPMG - Kaiser San Diego
🇺🇸La Jolla, California, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Kaiser Permanente San Francisco
🇺🇸San Francisco, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Stanford University
🇺🇸Stanford, California, United States
St. Joseph Hospital
🇺🇸Denver, Colorado, United States
Medical Center of the Rockies
🇺🇸Loveland, Colorado, United States
The Cardiac and Vascular Institute Research Foundation
🇺🇸Gainesville, Florida, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
NCH Healthcare System
🇺🇸Naples, Florida, United States
Sarasota Memorial Health Care System
🇺🇸Sarasota, Florida, United States
Tallahassee Research Institute
🇺🇸Tallahassee, Florida, United States
Emory University Hospital Midtown / Emory University - St. Joseph's Hospital
🇺🇸Atlanta, Georgia, United States
Piedmont Healthcare, Inc.
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Ascension St. Vincent Heart Center Cardiovascular Research Institute
🇺🇸Indianapolis, Indiana, United States
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
William Beaumont Hospital - Royal Oak
🇺🇸Royal Oak, Michigan, United States
St. Mary's of Ascension Research
🇺🇸Saginaw, Michigan, United States
Fairview Health Services
🇺🇸Maplewood, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Providence St. Patrick Hospital
🇺🇸Missoula, Montana, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Cooper Health Systems
🇺🇸Camden, New Jersey, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Rutgers Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital
🇺🇸Bronx, New York, United States
State University of New York at Buffalo
🇺🇸Buffalo, New York, United States
Columbia University Irving Medical Center/NYPH
🇺🇸New York, New York, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset
🇺🇸New York, New York, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Sanford Medical Center Fargo
🇺🇸Fargo, North Dakota, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
TriHealth-Bethesda North Hospital
🇺🇸Cincinnati, Ohio, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Cardiovascular Research Group
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Heart Institute at Hillcrest Medical Center
🇺🇸Tulsa, Oklahoma, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Penn State Hershey
🇺🇸Hershey, Pennsylvania, United States
Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Pinnacle Health Cardiovascular Institute/UPMC Pinnacle
🇺🇸Wormleysburg, Pennsylvania, United States
Lankenau Heart Institute
🇺🇸Wynnewood, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Erlanger Health System
🇺🇸Chattanooga, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
HCA Houston Healthcare Medical Center
🇺🇸Houston, Texas, United States
Baylor College of Medicine St. Luke's Medical Center
🇺🇸Houston, Texas, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
UTHealth/Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
Baylor Scott & White - The Heart Hospital - Plano
🇺🇸Plano, Texas, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
St. George Regional Hospital
🇺🇸Saint George, Utah, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Carilion Medical Center
🇺🇸Roanoke, Virginia, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Hamilton Health Services
🇨🇦Hamilton, Ontario, Canada
University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
🇨🇦Québec City, Quebec, Canada