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

Primary Purpose

Mitral Valve Regurgitation

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Mitral Valve Repair
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center
  • University of Colorado Denver
  • NorthShore University HealthSystem
  • Henry Ford Hospital
  • Morristown Medical Center
  • Carolinas Medical Center
  • The Heart Hospital Baylor Plano
  • University of Virginia Health System
  • Metro North Hospital & Health Service, The Prince Charles Hospital
  • Sydney Local Health District, Royal Prince Alfred Hospital
  • St. Paul's Hospital, Providence Health Care Research Institute
  • Sunnybrook Hospital
  • St Michael Hospital
  • Universitaetsklinikum Bonn, Medizinische Klinik II, Kardiologie
  • Hygeia Hospital
  • San Rafaelle Hospital
  • Inselspital, University Hospital Bern

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Edwards PASCAL Transcatheter Mitral Valve Repair System

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Major Adverse Events (MAE)
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
Device Success
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
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.
Clinical Success
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

Mitral Regurgitation Reduction
Mitral regurgitation reduction at 30 days, 6 months, and 1 year over baseline. Mitral regurgitation reduction was assessed per independent echocardiography core laboratory.
All-cause Mortality
All-cause mortality at 30 days, 6 months, 1 year
Recurrent Heart Failure Hospitalization
Recurrent heart failure hospitalization at 30 days, 6 months, 1 year
Re-intervention Rates for Mitral Regurgitation
Re-intervention rates for mitral regurgitation at 30 days, 6 months, 1 year
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
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, 1 year and annually thereafter
Change in Left Ventricular End Diastolic Volume (LVEDV)
Change in Left Ventricular End Diastolic Volume (LVEDV) at 6 months, and 1 year over baseline
Change in Left Ventricular End Systolic Volume (LVESV)
Change in Left Ventricular End Systolic Volume (LVESV) at 6 months and 1 year over baseline
Change in Pulmonary Artery Systolic Pressure
Change in Pulmonary Artery Systolic Pressure at 6 months, and 1 year over baseline
Change in Six Minute Walk Test (6MWT) Distance
Mean distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months, and 1 year compared to baseline
Change in Quality of Life (QoL) Score, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
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.
Change in Quality of Life (QoL) Score, as Measured by EQ5D
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.
Change in NYHA Functional Classification
Change in NYHA Functional Classification at 6 months and 1 year 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.
Change NT-pro-BNP Level
Change in NT-pro-BNP level at 6 months and 1 year over baseline
Change in BNP Level
Change in BNP level at 6 months over baseline
Change in Tricuspid Regurgitation (TR)
Change in TR over baseline at 6 months, and 1 year. TR grade was assessed by an independent echocardiography core lab using a 6-grade scale: None, trace, mild, mild-moderate, moderate-severe, or severe. Reduction by 1 or more grades reflects improvement from baseline, while an increase by 1 or more grades reflects worsening of TR.
Change in Effective Regurgitant Orifice Area (EROA)
Change in effective regurgitant orifice area (EROA) at 30 days, 6 months, and 1 year over baseline
Change in Mitral Regurgitant Volume
Change in mitral regurgitant volume at 30 days, 6 months and 1 year over baseline

Full Information

First Posted
May 26, 2017
Last Updated
July 26, 2022
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT03170349
Brief Title
The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
Acronym
CLASP
Official Title
The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 27, 2017 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Mitral Valve Repair
Intervention Description
Minimal Invasive Transcatheter Mitral Valve Repair
Primary Outcome Measure Information:
Title
Number of Participants With Major Adverse Events (MAE)
Description
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
30 days
Title
Device Success
Description
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.
Time Frame
Exit from the cardiac catheterization laboratory
Title
Number of Participants With Procedural Success
Description
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.
Time Frame
through discharge
Title
Clinical Success
Description
Procedural success with evidence of MR reduction ≤ MR2+ and without MAEs at 30 days. Mitral regurgitation reduction was assessed per independent echocardiography core laboratory.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Mitral Regurgitation Reduction
Description
Mitral regurgitation reduction at 30 days, 6 months, and 1 year over baseline. Mitral regurgitation reduction was assessed per independent echocardiography core laboratory.
Time Frame
baseline, 30 days, 6 months, 1 year
Title
All-cause Mortality
Description
All-cause mortality at 30 days, 6 months, 1 year
Time Frame
30 days, 6 months, 1 year
Title
Recurrent Heart Failure Hospitalization
Description
Recurrent heart failure hospitalization at 30 days, 6 months, 1 year
Time Frame
30 days , 6 months, 1 year
Title
Re-intervention Rates for Mitral Regurgitation
Description
Re-intervention rates for mitral regurgitation at 30 days, 6 months, 1 year
Time Frame
30 days, 6 months and 1 year
Title
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
Description
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, 1 year and annually thereafter
Time Frame
6 months, 1 year
Title
Change in Left Ventricular End Diastolic Volume (LVEDV)
Description
Change in Left Ventricular End Diastolic Volume (LVEDV) at 6 months, and 1 year over baseline
Time Frame
6 months, 1 year
Title
Change in Left Ventricular End Systolic Volume (LVESV)
Description
Change in Left Ventricular End Systolic Volume (LVESV) at 6 months and 1 year over baseline
Time Frame
6 months, 1 year
Title
Change in Pulmonary Artery Systolic Pressure
Description
Change in Pulmonary Artery Systolic Pressure at 6 months, and 1 year over baseline
Time Frame
baseline, 6 months, 1 year
Title
Change in Six Minute Walk Test (6MWT) Distance
Description
Mean distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months, and 1 year compared to baseline
Time Frame
6 months, 1 year
Title
Change in Quality of Life (QoL) Score, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
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.
Time Frame
baseline, 30 days, 6 months, 1 year
Title
Change in Quality of Life (QoL) Score, as Measured by EQ5D
Description
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.
Time Frame
baseline, 30 days, 6 months, 1 year
Title
Change in NYHA Functional Classification
Description
Change in NYHA Functional Classification at 6 months and 1 year 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.
Time Frame
baseline, 6 months, 1 year
Title
Change NT-pro-BNP Level
Description
Change in NT-pro-BNP level at 6 months and 1 year over baseline
Time Frame
baseline, 6 months, 1 year
Title
Change in BNP Level
Description
Change in BNP level at 6 months over baseline
Time Frame
baseline, 6 months, 1 year
Title
Change in Tricuspid Regurgitation (TR)
Description
Change in TR over baseline at 6 months, and 1 year. TR grade was assessed by an independent echocardiography core lab using a 6-grade scale: None, trace, mild, mild-moderate, moderate-severe, or severe. Reduction by 1 or more grades reflects improvement from baseline, while an increase by 1 or more grades reflects worsening of TR.
Time Frame
6 months, 1 year
Title
Change in Effective Regurgitant Orifice Area (EROA)
Description
Change in effective regurgitant orifice area (EROA) at 30 days, 6 months, and 1 year over baseline
Time Frame
baseline, 30 days, 6 months, 1 year
Title
Change in Mitral Regurgitant Volume
Description
Change in mitral regurgitant volume at 30 days, 6 months and 1 year over baseline
Time Frame
baseline, 30 days, 6 months, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gideon Cohen, MD
Organizational Affiliation
Sunnybrook Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulrich Schafer, MD
Organizational Affiliation
Bundeswehrzentralkrankenhaus Koblenz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Molly Szerlip, MD
Organizational Affiliation
The Heart Hospital Baylor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Metro North Hospital & Health Service, The Prince Charles Hospital
City
Brisbane
State/Province
Chermside
ZIP/Postal Code
QLD 4032
Country
Australia
Facility Name
Sydney Local Health District, Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
St. Paul's Hospital, Providence Health Care Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6E 1M7
Country
Canada
Facility Name
Sunnybrook Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St Michael Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B-1W8
Country
Canada
Facility Name
Universitaetsklinikum Bonn, Medizinische Klinik II, Kardiologie
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Hygeia Hospital
City
Athens
ZIP/Postal Code
15123
Country
Greece
Facility Name
San Rafaelle Hospital
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Inselspital, University Hospital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33092709
Citation
Webb JG, Hensey M, Szerlip M, Schafer 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.
Results Reference
derived
PubMed Identifier
31255562
Citation
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, Schafer 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.
Results Reference
derived

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The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

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