The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

Completed · Not applicable

Conditions studied: Mitral Valve Regurgitation

In brief

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

Key facts

Study ID

NCT03170349

Run by

Edwards Lifesciences

People needed

124

Starts

2017-06-27

Expected to finish

2025-05-27

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Morristown Medical Center — Morristown, New Jersey, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• The Heart Hospital Baylor Plano — Plano, Texas, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• Metro North Hospital & Health Service, The Prince Charles Hospital — Brisbane, Chermside, Australia
• Sydney Local Health District, Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• St. Paul's Hospital, Providence Health Care Research Institute — Vancouver, British Columbia, Canada
• Sunnybrook Hospital — Toronto, Ontario, Canada
• St Michael Hospital — Toronto, Ontario, Canada
• Universitaetsklinikum Bonn, Medizinische Klinik II, Kardiologie — Bonn, Germany
• Hygeia Hospital — Athens, Greece
• San Rafaelle Hospital — Milan, Italy
• Inselspital, University Hospital Bern — Bern, Switzerland

Full record on ClinicalTrials.gov

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