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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03170349
Recruitment Status : Active, not recruiting
First Posted : May 31, 2017
Results First Posted : December 1, 2021
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 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
Actual Primary Completion Date : July 30, 2020
Estimated Study Completion Date : August 2025

Arm Intervention/treatment
Experimental: Edwards PASCAL Transcatheter Mitral Valve Repair System Device: Mitral Valve Repair
Minimal Invasive Transcatheter Mitral Valve Repair




Primary Outcome Measures :
  1. Number of Participants With Major Adverse Events (MAE) [ Time Frame: 30 days ]
    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

  2. Device Success [ Time Frame: Exit from the cardiac catheterization laboratory ]
    Device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory.

  3. Number of Participants With Procedural Success [ Time Frame: through discharge ]
    Device success with evidence of mitral regurgitation reduction ≤ MR2+ at discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge. Mitral regurgitation was assessed per independent echocardiography core laboratory.

  4. Clinical Success [ Time Frame: 30 days ]
    Procedural success with evidence of MR reduction ≤ MR2+ and without MAEs at 30 days. Mitral regurgitation reduction was assessed per independent echocardiography core laboratory.


Secondary Outcome Measures :
  1. Mitral Regurgitation Reduction [ Time Frame: baseline, 30 days, 6 months ]
    Mitral regurgitation reduction at 30 days, 6 months over baseline. Mitral regurgitation reduction was assessed per independent echocardiography core laboratory.

  2. All-cause Mortality [ Time Frame: 30 days, 6 months ]
    All-cause mortality at 30 days, 6 months

  3. Recurrent Heart Failure Hospitalization [ Time Frame: 30 days , 6 months ]
    Recurrent heart failure hospitalization at 30 days, 6 months

  4. Re-intervention Rates for Mitral Regurgitation [ Time Frame: 30 days, 6 months ]
    Re-intervention rates for mitral regurgitation at 30 days, 6 months

  5. 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 [ Time Frame: 6 months ]
    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 6 months

  6. Change in Left Ventricular End Diastolic Volume (LVEDV) [ Time Frame: 6 months ]
    Change in Left Ventricular End Diastolic Volume (LVEDV) at 6 months over baseline

  7. Change in Left Ventricular End Systolic Volume (LVESV) [ Time Frame: 6 months ]
    Change in Left Ventricular End Systolic Volume (LVESV) at 6 months over baseline

  8. Change in Pulmonary Artery Systolic Pressure [ Time Frame: baseline, 6 months ]
    Change in Pulmonary Artery Systolic Pressure at 6 months over baseline

  9. Change in Six Minute Walk Test (6MWT) Distance [ Time Frame: 6 months ]
    Mean distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months compared to baseline

  10. Change in Quality of Life (QoL) Score, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: baseline, 30 days, 6 months ]
    Mean KCCQ Score. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status.

  11. Change in Quality of Life (QoL) Score, as Measured by EQ5D [ Time Frame: baseline, 30 days, 6 months ]
    Change in Quality of Life (QoL) score, as measured by EQ5D at 30 days, 6 months over baseline. The EQ5D self-reported questionnaire includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher health-related quality of life.

  12. Change in NYHA Functional Classification [ Time Frame: baseline, 6 months ]

    Change in NYHA Functional Classification at 6 months over baseline.

    NYHA Classification - The stages of heart failure:

    Class I - No symptoms and no limitation in ordinary physical activity.

    Class II - Mild symptoms and slight limitation during ordinary activity.

    Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.

    Class IV - Severe limitations. Experiences symptoms even while at rest.


  13. Change NT-pro-BNP Level [ Time Frame: baseline, 6 months ]
    Change in NT-pro-BNP level at 6 months over baseline

  14. Change in BNP Level [ Time Frame: baseline, 6 months ]
    Change in BNP level at 6 months over baseline

  15. Change in Tricuspid Regurgitation (TR) [ Time Frame: 6 months ]
    Change in TR over baseline at 6 months. TR grade was assessed by an independent echocardiography core lab using a 6-grade scale: None, trace, mild, mild-moderate, moderate-severe, or severe. Change from baseline was assessed at 6 months. Reduction by 1 or more grades reflects improvement from baseline, while an increase by 1 or more grades reflects worsening of TR.

  16. Change in Effective Regurgitant Orifice Area (EROA) [ Time Frame: baseline, 30 days, 6 months ]
    Change in effective regurgitant orifice area (EROA) at 30 days, 6 months over baseline

  17. Change in Mitral Regurgitant Volume [ Time Frame: baseline, 30 days, 6 months ]
    Change in mitral regurgitant volume at 30 days, 6 months over baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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


Locations
Show Show 17 study locations
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
  Study Documents (Full-Text)

Documents provided by Edwards Lifesciences:
Study Protocol  [PDF] August 20, 2018
Statistical Analysis Plan  [PDF] August 21, 2018

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
Results First Posted: December 1, 2021
Last Update Posted: December 1, 2021
Last Verified: November 2021
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