The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

NCT ID: NCT03170349

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-27
• Study Completion Date: 2025-05-27

Brief Summary

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

Detailed Description

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.

Conditions

Mitral Valve Regurgitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Edwards PASCAL Transcatheter Mitral Valve Repair System

Group Type: EXPERIMENTAL

Mitral Valve Repair

Intervention Type: DEVICE

Minimal Invasive Transcatheter Mitral Valve Repair

Interventions

Mitral Valve Repair

Minimal Invasive Transcatheter Mitral Valve Repair

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gideon Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Hospital

Ulrich Schafer, MD

Role: PRINCIPAL_INVESTIGATOR

BundeswehrZentralkrankenhaus Koblenz

Molly Szerlip, MD

Role: PRINCIPAL_INVESTIGATOR

The Heart Hospital Baylor

Locations

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

Countries

United States; Australia; Canada; Germany; Greece; Italy; Switzerland

References

Webb JG, Hensey M, Szerlip M, Schafer U, Cohen GN, Kar S, Makkar R, Kipperman RM, Spargias K, O'Neill WW, Ng MKC, Fam NP, Rinaldi MJ, Smith RL, Walters DL, Raffel CO, Levisay J, Latib A, Montorfano M, Marcoff L, Shrivastava M, Boone R, Gilmore S, Feldman TE, Lim DS. 1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study. JACC Cardiovasc Interv. 2020 Oct 26;13(20):2344-2357. doi: 10.1016/j.jcin.2020.06.019.

Reference Type: DERIVED

PMID: 33092709 (View on PubMed)

Lim DS, Kar S, Spargias K, Kipperman RM, O'Neill WW, Ng MKC, Fam NP, Walters DL, Webb JG, Smith RL, Rinaldi MJ, Latib A, Cohen GN, Schafer U, Marcoff L, Vandrangi P, Verta P, Feldman TE. Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study. JACC Cardiovasc Interv. 2019 Jul 22;12(14):1369-1378. doi: 10.1016/j.jcin.2019.04.034. Epub 2019 Jun 26.

Reference Type: DERIVED

PMID: 31255562 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-05

Identifier Type: -

Identifier Source: org_study_id