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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03170349
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mitral Valve Regurgitation Device: Mitral Valve Repair Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 245 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
Actual Study Start Date : June 27, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Edwards PASCAL Transcatheter Mitral Valve Repair System Device: Mitral Valve Repair
Minimal Invasive Transcatheter Mitral Valve Repair


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170349


Contacts
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Contact: Edwards TMTT Clinical Affairs +1 949-250-2500 TMTT_Clinical@edwards.com

Locations
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Sponsors and Collaborators
Edwards Lifesciences
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03170349    
Other Study ID Numbers: 2016-05
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases