The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study (CLASP)

• ClinicalTrials.gov Identifier: NCT03170349
• Recruitment Status: Active, not recruiting
• First Posted: May 31, 2017
• Last Update Posted: October 1, 2020
• Sponsor: Edwards Lifesciences
• Information provided by (Responsible Party): Edwards Lifesciences

Tracking Information

• First Submitted Date: May 26, 2017
• First Posted Date: May 31, 2017
• Last Update Posted Date: October 1, 2020
• Actual Study Start Date: June 27, 2017
• Actual Primary Completion Date: July 30, 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 2, 2017): Composite of major adverse events (MAE) defined as cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding and re-intervention for study device related complications at 30 days. [ Time Frame: The primary endpoint will be assessed at 30 days. ]
• Original Primary Outcome Measures (submitted: May 26, 2017): The primary safety endpoint for the study will assess the hierarchical composite of all-cause mortality or recurrent heart failure hospitalizations [ Time Frame: The primary endpoint will be assessed at 6 months. ]

Current Secondary Outcome Measures (submitted: November 2, 2017)

• Mitral regurgitation reduction [ Time Frame: 30 days, 6 months, 1 year ]
• All-cause mortality [ Time Frame: 30 days , 6 months, 1 year ]
• Recurrent heart failure hospitalization [ Time Frame: 30 days , 6 months, 1 year ]
• Change in Six Minute Walk Test (6MWT) distance [ Time Frame: 6 months and 1 year ]

Original Secondary Outcome Measures (submitted: May 26, 2017)

• The hierarchical composite of all-cause mortality or recurrent heart failure hospitalizations [ Time Frame: 30 days , 1 year , 2 year and 3 year ]
• Mitral regurgitation reduction [ Time Frame: 30 days, 6 months, 1 year , 2 year and 3 year ]
• All-cause mortality [ Time Frame: 30 days , 6 months, 1 year , 2 year and 3 year ]
• Recurrent heart failure hospitalization [ Time Frame: 30 days , 6 months, 1 year , 2 year and 3 year ]
• Change in Six Minute Walk Test (6MWT) distance [ Time Frame: 6 months and 1 year over baseline ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
• Official Title: The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Mitral Valve Regurgitation

Intervention

Device: Mitral Valve Repair

Minimal Invasive Transcatheter Mitral Valve Repair

Study Arms

Experimental: Edwards PASCAL Transcatheter Mitral Valve Repair System

Intervention: Device: Mitral Valve Repair

Publications *

• Webb JG, Hensey M, Szerlip M, Schäfer 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.
• 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, Schäfer 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: September 29, 2020): 124
• Original Estimated Enrollment (submitted: May 26, 2017): 130
• Estimated Study Completion Date: August 2025
• Actual Primary Completion Date: July 30, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Canada, Germany, Greece, Italy, Switzerland, United States

Administrative Information

• NCT Number: NCT03170349
• Other Study ID Numbers: 2016-05
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Edwards Lifesciences
• Study Sponsor: Edwards Lifesciences
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gideon Cohen, MD; Sunnybrook Hospital
• Principal Investigator: Ulrich Schafer, MD; University Medical Center Hamburg
• Principal Investigator: Molly Szerlip, MD; The Heart Hospital Baylor

• PRS Account: Edwards Lifesciences
• Verification Date: September 2020