Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03170349
Recruitment Status : Active, not recruiting
First Posted : May 31, 2017
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Tracking Information
First Submitted Date  ICMJE May 26, 2017
First Posted Date  ICMJE May 31, 2017
Last Update Posted Date October 1, 2020
Actual Study Start Date  ICMJE June 27, 2017
Actual Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mitral Valve Regurgitation
Intervention  ICMJE Device: Mitral Valve Repair
Minimal Invasive Transcatheter Mitral Valve Repair
Study Arms  ICMJE Experimental: Edwards PASCAL Transcatheter Mitral Valve Repair System
Intervention: Device: Mitral Valve Repair
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 29, 2020)
124
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2017)
130
Estimated Study Completion Date  ICMJE August 2025
Actual Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Germany,   Greece,   Italy,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03170349
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: Undecided
Responsible Party Edwards Lifesciences
Study Sponsor  ICMJE Edwards Lifesciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP