The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:June 27, 2017
End Date:January 2024
Contact:Edwards TMTT Clinical Affairs
Email:TMTT_Clinical@edwards.com
Phone:+1 949-250-2500

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The purpose of this study is to assess the safety, performance and clinical outcomes of the
Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.

The purpose of this study is to assess the safety, performance and clinical outcomes of the
Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System. This is a multi-center,
multi-national, prospective, single arm, safety, performance and clinical outcomes study.

Inclusion Criteria:

- Signed and dated IRB/ethics committee approved study consent form prior to study
related procedures

- Eighteen (18) years of age or older

- New York Heart Association (NYHA) Functional Class II-IVa heart failure despite
optimal medical therapy

- Candidacy for surgical mitral valve repair or replacement determined by Heart Team
evaluation

- Clinically significant mitral regurgitation (moderate-to-severe or severe mitral
regurgitation) confirmed by transesophageal echocardiography (TEE) and transthoracic
echocardiography (TTE).

- The primary regurgitant jet is non-commissural. If a secondary jet exists, it must be
considered clinically insignificant.

- Mitral valve area (MVA) ≥ 4.0 cm² as measured by planimetry. If MVA by planimetry is
not measurable, pressure half-time measurement is acceptable.

Exclusion Criteria:

- Patient in whom a TEE is contraindicated or screening TEE is unsuccessful

- Leaflet anatomy which may preclude PASCAL device implantation, proper device
positioning on the leaflets, or sufficient reduction in mitral regurgitation.

- Mitral valve area (MVA) < 4.0 cm² as measured by planimetry (If MVA by planimetry is
not measurable, PHT measurement is acceptable)

- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation

- Physical evidence of right sided congestive heart failure and echocardiographic
evidence of severe right ventricular dysfunction

- Concurrent medical condition with a life expectancy of less than 12 months in the
judgment of the Investigator

- Patient is currently participating or has participated in another investigational drug
or device clinical study where the primary study endpoint was not reached at time of
enrollment

- Patient is under guardianship
We found this trial at
9
sites
Plano, Texas 75093
Principal Investigator: Robert L Smith, MD
Phone: 469-814-4737
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Michael Rinaldi, MD
Phone: 704-355-4794
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Charlotte, NC
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Saibal Kar, MD
Phone: 310-248-8515
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: John Carroll, MD
Phone: 303-724-6473
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Aurora, CO
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Brisbane, Chermside 4029
Principal Investigator: Darren Walters, MD
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Brisbane,
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Principal Investigator: D. Scott Lim, MD
Phone: 434-982-1058
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Charlottesville, VA
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: William O'Neill, MD
Phone: 313-916-7430
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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Evanston, Illinois
Principal Investigator: Ted Feldman, MD
Phone: 847-570-2368
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Evanston, IL
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Morristown, New Jersey 07962
Principal Investigator: Robert Kipperman, MD
Phone: 973-971-4099
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Morristown, NJ
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