Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
Purpose
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)
Conditions
- Degenerative Mitral Valve Disease
- Mitral Regurgitation
- Mitral Insufficiency
- Functional Mitral Regurgitation
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Eighteen (18) years of age or older - Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements. - Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only). - Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only) - Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip - Mitral regurgitation (3+ to 4+) by echo - Suitable valve and regurgitant jet morphology - 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) - LVEF ≥ 20% (and ≤ 50%; CLASP IIF cohort only)
Exclusion Criteria
- Patient in whom a TEE is contraindicated or screening TEE is unsuccessful - Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation - Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, Status ≤5 heart transplantation) (ACC/AHA Stage D heart failure) - Clinically significant, untreated coronary artery disease - Recent stroke - Other severe valve disorders requiring intervention - Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months - Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair) - Severe tricuspid regurgitation or tricuspid valve disease requiring surgery - Active rheumatic heart disease or rheumatic etiology for MR - Severe aortic stenosis or regurgitation - Known history of untreated, severe carotid stenosis - Recent deep vein thrombosis (DVT) or pulmonary embolism (PE) - Severe COPD - 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 - 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 where the primary study endpoint was not reached at time of enrollment - Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Edwards PASCAL System - CLASP IID |
Transcatheter mitral valve repair with the Edwards PASCAL System in patients with degenerative mitral regurgitation |
|
|
Active Comparator Abbott Mitraclip System - CLASP IID |
Transcatheter mitral valve repair with the Abbott Mitraclip System in patients with degenerative mitral regurgitation |
|
|
Experimental Edwards PASCAL System - CLASP IIF |
Transcatheter mitral valve repair with the Edwards PASCAL System in patients on guideline directed medical therapy with functional mitral regurgitation |
|
|
Active Comparator Abbott Mitraclip System - CLASP IIF |
Transcatheter mitral valve repair with the Abbott Mitraclip System in patients on guideline directed medical therapy with functional mitral regurgitation |
|
|
Experimental Edwards PASCAL System - Single-Arm Registry |
Transcatheter mitral valve repair with the Edwards PASCAL System in patients with mitral regurgitation who were deemed non-randomizable by a central screening committee (CSC) due to complex anatomical features described in the current MitraClip Instructions for Use (IFU) but were considered suitable for the PASCAL system. |
|
Recruiting Locations
Banner University Medical Center
Phoenix, Arizona 85006
Phoenix, Arizona 85006
Abrazo Arizona Heart Hospital
Phoenix, Arizona 85016
Phoenix, Arizona 85016
Scripps Memorial Hospital La Jolla
La Jolla, California 92071
La Jolla, California 92071
Cedars Sinai Medical Center
Los Angeles, California 90048
Los Angeles, California 90048
Sutter Medical Center-Sacramento
Sacramento, California 95618
Sacramento, California 95618
Kaiser Permanente San Francisco
San Francisco, California 94118
San Francisco, California 94118
University of California, San Francisco
San Francisco, California 94143
San Francisco, California 94143
Stanford University
Stanford, California 94305
Stanford, California 94305
Los Robles Hospital and Medical Center
Thousand Oaks, California 91360
Thousand Oaks, California 91360
Medical Center of the Rockies
Loveland, Colorado 80538
Loveland, Colorado 80538
Medstar Washington Hospital Center
Washington, District of Columbia 20010
Washington, District of Columbia 20010
The Cardiac and Vascular Institute Research Foundation
Gainesville, Florida 32605
Gainesville, Florida 32605
Mount Sinai
Miami Beach, Florida 33140
Miami Beach, Florida 33140
NCH Healthcare System Naples
Naples, Florida 34102
Naples, Florida 34102
AdventHealth Orlando
Orlando, Florida 32803
Orlando, Florida 32803
Piedmont Healthcare
Atlanta, Georgia 30309
Atlanta, Georgia 30309
Emory University Hospital and Emory University Hospital Midtown
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Northwestern University
Chicago, Illinois 60611
Chicago, Illinois 60611
St. Vincent Heart Center
Carmel, Indiana 46290
Carmel, Indiana 46290
University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
Iowa City, Iowa 52242
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Brigham and Woman's Hospital
Boston, Massachusetts 02115
Boston, Massachusetts 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
University of Michigan
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Mayo Clinic
Rochester, Minnesota 55905
Rochester, Minnesota 55905
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota 56303
Saint Cloud, Minnesota 56303
St.Luke's Hospital of Kansas City
Kansas City, Missouri 64111
Kansas City, Missouri 64111
Washington University/Barnes Jewish Hospital
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Morristown Medical Center
Morristown, New Jersey 07960
Morristown, New Jersey 07960
Rutgers-RWJMS
New Brunswick, New Jersey 08901
New Brunswick, New Jersey 08901
Albany Medical College
Albany, New York 12208
Albany, New York 12208
State University of New York at Buffalo
Buffalo, New York 14203
Buffalo, New York 14203
NYU Langone Hospital - Long Island
Mineola, New York 11501
Mineola, New York 11501
NYU Langone Health
New York, New York 10016
New York, New York 10016
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York 10032
New York, New York 10032
Lenox Hill Hospital and North Shore University
New York, New York 10075
New York, New York 10075
Rochester General Hospital
Rochester, New York 14621
Rochester, New York 14621
St. Francis Hospital
Roslyn, New York 11576
Roslyn, New York 11576
Atrium Health/Sanger Heart & Vascular Institute
Charlotte, North Carolina 28203
Charlotte, North Carolina 28203
The Christ Hospital
Cincinnati, Ohio 45219-2906
Cincinnati, Ohio 45219-2906
Cleveland Clinic Foundation
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Oklahoma Cardiovascular
Oklahoma City, Oklahoma 73120
Oklahoma City, Oklahoma 73120
Oklahoma Heart Institute
Tulsa, Oklahoma 74104
Tulsa, Oklahoma 74104
Oregon Health & Science University
Portland, Oregon 97239
Portland, Oregon 97239
Hospital of the University of Pennsylvania/Penn Presbyterian Medical Center
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Pinnacle Health Cardiovascular Institute/ UPMC Pinnacle Harrisburg
Wormleysburg, Pennsylvania 17043
Wormleysburg, Pennsylvania 17043
Lankenau Medical Center
Wynnewood, Pennsylvania 19096
Wynnewood, Pennsylvania 19096
WellSpan York Hospital
York, Pennsylvania 17405
York, Pennsylvania 17405
Baptist Memorial Hospital Memphis
Memphis, Tennessee 38138
Memphis, Tennessee 38138
Centennial Medical Center
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Saint Thomas Heart at Saint Thomas West
Nashville, Tennessee 37205
Nashville, Tennessee 37205
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
HCA Houston Healthcare Medical Center
Houston, Texas 77004
Houston, Texas 77004
Baylor College of Medicine
Houston, Texas 77030
Houston, Texas 77030
Houston Methodist Hospital
Houston, Texas 77030
Houston, Texas 77030
The University of Texas Health Science Center at Houston
Houston, Texas 77030
Houston, Texas 77030
The Heart Hospital Baylor Plano
Plano, Texas 75093
Plano, Texas 75093
Intermountain Medical Center
Salt Lake City, Utah 84107
Salt Lake City, Utah 84107
University of Virginia
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
Norfolk, Virginia 23507
Swedish Medical Center
Seattle, Washington 98122
Seattle, Washington 98122
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
More Details
- NCT ID
- NCT03706833
- Status
- Recruiting
- Sponsor
- Edwards Lifesciences
Detailed Description
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 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) Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.