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Clinical Trials/NCT03170349
NCT03170349CompletedNot Applicable

The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

Edwards Lifesciences33 sites in 7 countries124 target enrollmentStarted: June 27, 2017Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
124
Locations
33
Primary Endpoint
Number of Participants With Major Adverse Events (MAE)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Edwards PASCAL Transcatheter Mitral Valve Repair System

Experimental

Intervention: Mitral Valve Repair (Device)

Outcomes

Primary Outcomes

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 post-implant. MAEs during the first year of post-implant follow-up were adjudicated by a Clinical Events Committee of independent heart specialist physicians.

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.

Number of Participants With Procedural Success

Time Frame: through discharge

Device success with evidence of mitral regurgitation reduction to ≤ 2+ (mild-moderate) at discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge. Mitral regurgitation was assessed by independent echocardiographic core laboratory review of transthoracic echocardiography (TTE) imaging.

Clinical Success

Time Frame: 30 days

Procedural success with evidence of MR reduction to ≤ 2+ (mild-moderate) and without MAEs at 30 days. Mitral regurgitation was assessed by independent echocardiographic core laboratory review of transthoracic echocardiography (TTE) imaging.

Secondary Outcomes

  • Change in NT-proBNP, Baseline to 1-Year Visit(Baseline and 1 Year)
  • Recurrent Heart Failure Hospitalization(30 days , 6 months, 1 year, 2 year, 3 year, 4 year)
  • Change in PASP, Baseline to 4-Year Visit(Baseline and 4 Years)
  • 6MWD by Study Visit(Baseline, 6 Months and 1 Year)
  • Change in 6MWD, Baseline to 6-Month Visit(Baseline and 6 Months)
  • Change in 6MWD, Baseline to 1-Year Visit(Baseline and 1 Year)
  • Mitral Regurgitation Reduction(Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years)
  • Reintervention Rates for Mitral Regurgitation(30 days, 6 months, 1 year, 2 year, 3 year, 4 year)
  • LVEDV by Study Visit(Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years)
  • Change in LVEDV, Baseline to 3-Year Visit(Baseline and 3 Years)
  • Change in LVESV, Baseline to 2-Year Visit(Baseline and 2 Years)
  • Change in LVESV, Baseline to 3-Year Visit(Baseline and 3 Years)
  • Change in PASP, Baseline to 6-Month Visit(Baseline and 6 Months)
  • All-cause Mortality(30 days, 6 months, 1 year, 2 years, 3 years, 4 Years)
  • Change in Mitral Regurgitant Volume, Baseline to 4-Year Visit(Baseline and 4 Years)
  • Change in EQ5D VAS Score, Baseline to 1-Year Visit(Baseline and 1 Year)
  • NT-proBNP by Study Visit(Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years)
  • Change in NT-proBNP, Baseline to 3-Year Visit(Baseline and 3 Years)
  • Change in NT-proBNP, Baseline to 2-Year Visit(Baseline and 2 Years)
  • Change in BNP, Baseline to 6-Month Visit(Baseline and 6 Months)
  • Change BNP, Baseline to 1-Year Visit(Baseline and 1 Year)
  • KCCQ OS Score by Study Visit(Baseline, 30 Days, 6 Months and 1 Year)
  • Change in Tricuspid Regurgitation From Baseline(6 Month, 1 Year, 2 Years, 3 Years, 4 Years)
  • Mitral EROA by Study Visit(Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years)
  • Change in NYHA Functional Classification(Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years)
  • Composite of Major Adverse Events (MAEs) Defined as Cardiovascular Mortality, Stroke, Myocardial Infarction, New Need for Renal Replacement Therapy, Severe Bleeding and Reintervention for Study Device Related Complications.(6 months, 1 year, 2 year, 3 year, 4 year)
  • Change in LVEDV, Baseline to 6-Month Visit(Baseline and 6 Months)
  • Change in LVEDV, Baseline to 1-Year Visit(Baseline and 1 Year)
  • Change in LVEDV, Baseline to 2-Year Visit(Baseline and 2 Years)
  • Change in LVEDV, Baseline to 4-Year Visit(Baseline and 4 Years)
  • LVESV by Study Visit(Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years)
  • Change in LVESV, Baseline to 6-Month Visit(Baseline and 6 Months)
  • Change in LVESV, Baseline to 1-Year Visit(Baseline and 1 Year)
  • Change in LVESV, Baseline to 4-Year Visit(Baseline and 4 Years)
  • PASP by Study Visit(Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years)
  • Change in PASP, Baseline to 1-Year Visit(Baseline and 1 Year)
  • Change in PASP, Baseline to 2-Year Visit(Baseline and 2 Years)
  • Change in PASP, Baseline to 3-Year Visit(Baseline and 3 Years)
  • Change in KCCQ OS Score, Baseline to 30-Day Visit(Baseline and 30 Days)
  • Change in KCCQ OS Score, Baseline to 6-Month Visit(Baseline and 6 Months)
  • Change in KCCQ OS Score, Baseline to 1-Year Visit(Baseline and 1 Year)
  • EQ5D VAS Score by Study Visit(Baseline, 30 Days, 6 Months and 1 Year)
  • Change in EQ5D VAS Score, Baseline to 30-Day Visit(Baseline and 30 Days)
  • Change in EQ5D VAS Score, Baseline to 6-Month Visit(Baseline and 6 Months)
  • Change in NT-proBNP, Baseline to 6-Month Visit(Baseline and 6 Months)
  • Change in NT-proBNP, Baseline to 4-Year Visit(Baseline and 4 Years)
  • BNP by Study Visit(Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years)
  • Change in BNP, Baseline to 2-Year Visit(Baseline and 2 Years)
  • Change in BNP, Baseline to 3-Year Visit(Baseline and 3 Years)
  • Change in BNP, Baseline to 4-Year Visit(Baseline and 4 Years)
  • Change in Mitral EROA, Baseline to 30-Day Visit(Baseline and 30 Days)
  • Change in Mitral EROA, Baseline to 6-Month Visit(Baseline and 6 Months)
  • Change in Mitral EROA, Baseline to 1-Year Visit(Baseline and 1 Year)
  • Change in Mitral EROA, Baseline to 2-Year Visit(Baseline and 2 Years)
  • Change in Mitral EROA, Baseline to 3-Year Visit(Baseline and 3 Years)
  • Change in Mitral EROA, Baseline to 4-Year Visit(Baseline and 4 Years)
  • Mitral Regurgitant Volume by Study Visit(Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years)
  • Change in Mitral Regurgitant Volume, Baseline to 30-Day Visit(Baseline and 30 Days)
  • Change in Mitral Regurgitant Volume, Baseline to 6-Month Visit(Baseline and 6 Months)
  • Change in Mitral Regurgitant Volume, Baseline to 1-Year Visit(Baseline and 1 Year)
  • Change in Mitral Regurgitant Volume, Baseline to 2-Year Visit(Baseline and 2 Years)
  • Change in Mitral Regurgitant Volume, Baseline to 3-Year Visit(Baseline and 3 Years)

Investigators

Sponsor
Edwards Lifesciences
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (33)

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