RECRUITING

Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

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Conditions

Tricuspid RegurgitationTricuspid Valve InsufficiencyTricuspid Valve Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2019-12-11
Study Completion:2031-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04097145

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eighteen (18) years of age or older
  2. * Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.
  3. * Severe or greater tricuspid regurgitation
  4. * New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months
  5. * 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
  6. * Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements
  1. * Tricuspid valve anatomy not evaluable by TTE or TEE
  2. * Tricuspid valve anatomy precludes proper device deployment and function
  3. * 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)
  4. * Presence of trans-tricuspid pacemaker or defibrillator leads which meet one of the following:
  5. 1. Would prevent proper TR reduction due to interaction of the lead with the leaflets
  6. 2. Were implanted in the RV within the last 90 days prior to the point of enrollment
  7. * Primary non-degenerative tricuspid disease
  8. * Previous tricuspid valve repair or replacement that would interfere with placement of PASCAL
  9. * Clinically significant, untreated coronary artery disease requiring revascularization, unstable angina, evidence of acute coronary syndrome, recent myocardial infarction
  10. * Significant intra-cardiac mass, thrombus, or vegetation per echo core lab assessment
  11. * Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 90 days
  12. * Recent Stroke
  13. * Active gastrointestinal (GI) bleeding
  14. * 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
  15. * 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
  16. * Any of the following cardiovascular procedures:
  17. 1. Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days prior to the point of enrollment
  18. 2. Carotid surgery within 30 days prior to the point of enrollment
  19. 3. Direct current cardioversion within the last 30 days prior to the point of enrollment
  20. 4. Leadless RV pacemaker implant within the last 30 days prior to the point of enrollment
  21. 5. Cardiac surgery within 90 days prior to the point of enrollment
  22. * Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
  23. * Known history of untreated severe symptomatic carotid stenosis or asymptomatic carotid stenosis
  24. * Active endocarditis within the last 90 days or infection requiring antibiotic therapy within the last 14 days
  25. * Patient is oxygen-dependent or requires continuous home oxygen
  26. * Pregnant, breastfeeding, or planning pregnancy within the next 12 months (365 days)
  27. * Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
  28. * Patient is currently participating in another investigational biologic, drug, or device clinical study
  29. * Patient has other medical, social, or psychological conditions that preclude appropriate consent and follow-up, or the patient is under guardianship
  30. * Any patient considered to be vulnerable

Contacts and Locations

Study Contact

Edwards TMTT Clinical Affairs
CONTACT
(949) 250-2500
TMTT_Clinical@edwards.com

Principal Investigator

Martin B. Leon, MD
PRINCIPAL_INVESTIGATOR
Columbia University
Michael J. Mack, MD
PRINCIPAL_INVESTIGATOR
Baylor Scott and White Health
Charles Davidson, MD
PRINCIPAL_INVESTIGATOR
Northwestern University
Allen Anderson, MD
STUDY_CHAIR
UT Health San Antonio
Gorav Ailawadi, MD
STUDY_CHAIR
University of Michigan

Study Locations (Sites)

Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
United States
Tucson Medical Center Healthcare
Tucson, Arizona, 85712
United States
University of California, Irvine
Irvine, California, 92868
United States
SCPMG - Kaiser San Diego
La Jolla, California, 92037
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
UCLA Medical Center
Los Angeles, California, 90095
United States
Kaiser Permanente San Francisco
San Francisco, California, 94118
United States
University of California, San Francisco
San Francisco, California, 94143
United States
Stanford University
Stanford, California, 94305
United States
St. Joseph Hospital
Denver, Colorado, 80218
United States
Medical Center of the Rockies
Loveland, Colorado, 80538
United States
The Cardiac and Vascular Institute Research Foundation
Gainesville, Florida, 32605
United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140
United States
NCH Healthcare System
Naples, Florida, 34102
United States
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
United States
Tallahassee Research Institute
Tallahassee, Florida, 32308
United States
Emory University Hospital Midtown / Emory University - St. Joseph's Hospital
Atlanta, Georgia, 30308
United States
Piedmont Healthcare, Inc.
Atlanta, Georgia, 30309
United States
Northwestern University
Chicago, Illinois, 60611
United States
Ascension St. Vincent Heart Center Cardiovascular Research Institute
Indianapolis, Indiana, 46290
United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
United States
Ochsner Medical Center
New Orleans, Louisiana, 70121
United States
Johns Hopkins
Baltimore, Maryland, 21287
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073
United States
St. Mary's of Ascension Research
Saginaw, Michigan, 48601
United States
Fairview Health Services
Maplewood, Minnesota, 55109
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Providence St. Patrick Hospital
Missoula, Montana, 59802
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Cooper Health Systems
Camden, New Jersey, 09103
United States
Morristown Medical Center
Morristown, New Jersey, 07962
United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
United States
Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital
Bronx, New York, 10467
United States
State University of New York at Buffalo
Buffalo, New York, 14203
United States
Columbia University Irving Medical Center/NYPH
New York, New York, 10032
United States
Weill Cornell Medicine
New York, New York, 10065
United States
Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset
New York, New York, 10075
United States
Rochester General Hospital
Rochester, New York, 14621
United States
St. Francis Hospital
Roslyn, New York, 11576
United States
University of North Carolina
Chapel Hill, North Carolina, 27517
United States
Sanford Medical Center Fargo
Fargo, North Dakota, 58104
United States
The Christ Hospital
Cincinnati, Ohio, 45219
United States
TriHealth-Bethesda North Hospital
Cincinnati, Ohio, 45242
United States
The Ohio State University
Columbus, Ohio, 43210
United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
United States
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, 73120
United States
Oklahoma Heart Institute at Hillcrest Medical Center
Tulsa, Oklahoma, 74104
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Penn State Hershey
Hershey, Pennsylvania, 17033
United States
Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Pinnacle Health Cardiovascular Institute/UPMC Pinnacle
Wormleysburg, Pennsylvania, 17043
United States
Lankenau Heart Institute
Wynnewood, Pennsylvania, 19096
United States
Medical University of South Carolina
Charleston, South Carolina, 29245
United States
Erlanger Health System
Chattanooga, Tennessee, 37403
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
United States
HCA Houston Healthcare Medical Center
Houston, Texas, 77004
United States
Baylor College of Medicine St. Luke's Medical Center
Houston, Texas, 77030
United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
UTHealth/Memorial Hermann Hospital
Houston, Texas, 77030
United States
Baylor Scott & White - The Heart Hospital - Plano
Plano, Texas, 75093
United States
Intermountain Medical Center
Murray, Utah, 84107
United States
St. George Regional Hospital
Saint George, Utah, 84790
United States
University of Virginia Health System
Charlottesville, Virginia, 22908
United States
Virginia Commonwealth University
Richmond, Virginia, 23298
United States
Carilion Medical Center
Roanoke, Virginia, 24014
United States
Virginia Mason Medical Center
Seattle, Washington, 98101
United States
Swedish Medical Center
Seattle, Washington, 98122
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Edwards Lifesciences

  • Martin B. Leon, MD, PRINCIPAL_INVESTIGATOR, Columbia University
  • Michael J. Mack, MD, PRINCIPAL_INVESTIGATOR, Baylor Scott and White Health
  • Charles Davidson, MD, PRINCIPAL_INVESTIGATOR, Northwestern University
  • Allen Anderson, MD, STUDY_CHAIR, UT Health San Antonio
  • Gorav Ailawadi, MD, STUDY_CHAIR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-11
Study Completion Date2031-12-31

Study Record Updates

Study Start Date2019-12-11
Study Completion Date2031-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Tricuspid Regurgitation
  • Tricuspid Valve Insufficiency
  • Tricuspid Valve Disease