ACTIVE_NOT_RECRUITING

Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

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Conditions

Degenerative Mitral Valve DiseaseMitral RegurgitationMitral InsufficiencyFunctional Mitral Regurgitation

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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 Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)

Official Title

Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System Compared to Abbott MitraClip in Patients With Mitral Regurgitation

Quick Facts

Study Start:2018-11-30
Study Completion:2031-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03706833

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. * Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements.
  3. * Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only).
  4. * Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only)
  5. * Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip
  6. * Mitral regurgitation (3+ to 4+) by echo
  7. * Suitable valve and regurgitant jet morphology
  8. * Elevated corrected BNP \> 400 pg/ml or corrected NT-pro BNP of \> 900 pg/ml or heart failure hospitalization within the past 12 months (CLASP IIF cohort only)
  9. * LVEF ≥ 20% (and ≤ 50%; CLASP IIF cohort only)
  1. * Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
  2. * Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation
  3. * Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, Status ≤5 heart transplantation) (ACC/AHA Stage D heart failure)
  4. * Clinically significant, untreated coronary artery disease
  5. * Recent stroke
  6. * Other severe valve disorders requiring intervention
  7. * Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
  8. * Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair)
  9. * Severe tricuspid regurgitation or tricuspid valve disease requiring surgery
  10. * Active rheumatic heart disease or rheumatic etiology for MR
  11. * Severe aortic stenosis or regurgitation
  12. * Known history of untreated, severe carotid stenosis
  13. * Recent deep vein thrombosis (DVT) or pulmonary embolism (PE)
  14. * Severe COPD
  15. * Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention and be adherent to an accepted method of contraception
  16. * Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
  17. * Patient is currently participating in another investigational biologic, drug or device clinical study where the primary study endpoint was not reached at time of enrollment
  18. * Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship

Contacts and Locations

Principal Investigator

Scott Lim, MD
PRINCIPAL_INVESTIGATOR
University of Virginia
Robert Smith, MD
PRINCIPAL_INVESTIGATOR
The Heart Hospital Baylor Plano
Linda Gillam, MD
PRINCIPAL_INVESTIGATOR
Morristown Medical Center
Vinod Thourani, MD
PRINCIPAL_INVESTIGATOR
Piedmont Healthcare
Paul Grayburn, MD
PRINCIPAL_INVESTIGATOR
The Heart Hospital Baylor Plano
Brian K Whisenant, MD
PRINCIPAL_INVESTIGATOR
Intermountain Medical Center
Jörg Hausleiter, MD
PRINCIPAL_INVESTIGATOR
LMU München, Campus Gorsshadern
Ralph Stephan von Bardeleben, MD
PRINCIPAL_INVESTIGATOR
/ Universitätsmedizin Mainz- Zentrum für Kardiologie

Study Locations (Sites)

Banner University Medical Center
Phoenix, Arizona, 85006
United States
Abrazo Arizona Heart Hospital
Phoenix, Arizona, 85016
United States
TMC Healthcare
Tucson, Arizona, 85712
United States
Scripps Memorial Hospital La Jolla
La Jolla, California, 92071
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
UC Irvine
Orange, California, 92868
United States
Sutter Medical Center-Sacramento
Sacramento, California, 95618
United States
Sutter Bay Area
San Francisco, California, 94109
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
Los Robles Hospital and Medical Center
Thousand Oaks, California, 91360
United States
Medical Center of the Rockies
Loveland, Colorado, 80538
United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
The Cardiac and Vascular Institute Research Foundation
Gainesville, Florida, 32605
United States
Mount Sinai
Miami Beach, Florida, 33140
United States
NCH Healthcare System Naples
Naples, Florida, 34102
United States
AdventHealth Orlando
Orlando, Florida, 32803
United States
Piedmont Healthcare
Atlanta, Georgia, 30309
United States
Emory University Hospital and Emory University Hospital Midtown
Atlanta, Georgia, 30322
United States
Northwestern University
Chicago, Illinois, 60611
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
St. Vincent Heart Center
Carmel, Indiana, 46290
United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham and Woman's Hospital
Boston, Massachusetts, 02115
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, 56303
United States
St.Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
United States
Washington University/Barnes Jewish Hospital
St Louis, Missouri, 63110
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
Rutgers-RWJMS
New Brunswick, New Jersey, 08901
United States
Albany Medical College
Albany, New York, 12208
United States
State University of New York at Buffalo
Buffalo, New York, 14203
United States
NYU Langone Hospital - Long Island
Mineola, New York, 11501
United States
NYU Langone Health
New York, New York, 10016
United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, 10032
United States
Lenox Hill Hospital and North Shore University
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
Montefiore Medical Center
The Bronx, New York, 10467
United States
The Christ Hospital
Cincinnati, Ohio, 45219-2906
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Oklahoma Cardiovascular
Oklahoma City, Oklahoma, 73120
United States
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Hospital of the University of Pennsylvania/Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
Pinnacle Health Cardiovascular Institute/ UPMC Pinnacle Harrisburg
Wormleysburg, Pennsylvania, 17043
United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
United States
WellSpan York Hospital
York, Pennsylvania, 17405
United States
CVA Heart Institute Kingsport
Kingsport, Tennessee, 37660
United States
Baptist Memorial Hospital Memphis
Memphis, Tennessee, 38138
United States
Centennial Medical Center
Nashville, Tennessee, 37203
United States
Saint Thomas Heart at Saint Thomas West
Nashville, Tennessee, 37205
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
HCA Houston Healthcare Medical Center
Houston, Texas, 77004
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093
United States
Intermountain Medical Center
Salt Lake City, Utah, 84107
United States
University of Virginia
Charlottesville, Virginia, 22908
United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
United States
Swedish Medical Center
Seattle, Washington, 98122
United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
United States

Collaborators and Investigators

Sponsor: Edwards Lifesciences

  • Scott Lim, MD, PRINCIPAL_INVESTIGATOR, University of Virginia
  • Robert Smith, MD, PRINCIPAL_INVESTIGATOR, The Heart Hospital Baylor Plano
  • Linda Gillam, MD, PRINCIPAL_INVESTIGATOR, Morristown Medical Center
  • Vinod Thourani, MD, PRINCIPAL_INVESTIGATOR, Piedmont Healthcare
  • Paul Grayburn, MD, PRINCIPAL_INVESTIGATOR, The Heart Hospital Baylor Plano
  • Brian K Whisenant, MD, PRINCIPAL_INVESTIGATOR, Intermountain Medical Center
  • Jörg Hausleiter, MD, PRINCIPAL_INVESTIGATOR, LMU München, Campus Gorsshadern
  • Ralph Stephan von Bardeleben, MD, PRINCIPAL_INVESTIGATOR, / Universitätsmedizin Mainz- Zentrum für Kardiologie

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 Date2018-11-30
Study Completion Date2031-06-30

Study Record Updates

Study Start Date2018-11-30
Study Completion Date2031-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Degenerative Mitral Valve Disease
  • Mitral Regurgitation
  • Mitral Insufficiency
  • Functional Mitral Regurgitation