The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

Mitral Valve Regurgitation Clinical Trial

— CLASP  

Official title:

The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03170349
• Other study ID #: 2016-05
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 27, 2017
• Est. completion date: August 31, 2025

Study information

• Verified date: April 2024
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 124
• Est. completion date: August 31, 2025
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• Mitral Valve Repair
Minimal Invasive Transcatheter Mitral Valve Repair

Locations

Country	Name	City	State
Australia	Metro North Hospital & Health Service, The Prince Charles Hospital	Brisbane	Chermside
Australia	Sydney Local Health District, Royal Prince Alfred Hospital	Camperdown	New South Wales
Canada	St Michael Hospital	Toronto	Ontario
Canada	Sunnybrook Hospital	Toronto	Ontario
Canada	St. Paul's Hospital, Providence Health Care Research Institute	Vancouver	British Columbia
Germany	Universitaetsklinikum Bonn, Medizinische Klinik II, Kardiologie	Bonn
Greece	Hygeia Hospital	Athens
Italy	San Rafaelle Hospital	Milano
Switzerland	Inselspital, University Hospital Bern	Bern
United States	University of Colorado Denver	Aurora	Colorado
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Henry Ford Hospital	Detroit	Michigan
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Morristown Medical Center	Morristown	New Jersey
United States	The Heart Hospital Baylor Plano	Plano	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Greece,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days
Primary	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.	Exit from the cardiac catheterization laboratory
Primary	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.	through discharge
Primary	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.	30 days
Secondary	Mitral Regurgitation Reduction	Mitral regurgitation reduction at 30 days, 6 months, 1 year and annually thereafter over baseline. Mitral regurgitation reduction was assessed per independent echocardiography core laboratory.	baseline, 30 days, 6 months, 1 year, 2 year
Secondary	All-cause Mortality	All-cause mortality at 30 days, 6 months, 1 year and annually thereafter	30 days, 6 months, 1 year, 2 year
Secondary	Recurrent Heart Failure Hospitalization	Recurrent heart failure hospitalization at 30 days, 6 months, 1 year and annually thereafter	30 days , 6 months, 1 year, 2 year
Secondary	Re-intervention Rates for Mitral Regurgitation	Re-intervention rates for mitral regurgitation at 30 days, 6 months, 1 year and annually thereafter	30 days, 6 months, 1 year, 2 year
Secondary	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	6 months, 1 year, 2 year
Secondary	Change in Left Ventricular End Diastolic Volume (LVEDV)	Change in Left Ventricular End Diastolic Volume (LVEDV) at 6 months, and 1 year over baseline	6 months, 1 year, 2 year
Secondary	Change in Left Ventricular End Systolic Volume (LVESV)	Change in Left Ventricular End Systolic Volume (LVESV) at 6 months and 1 year over baseline	6 months, 1 year, 2 year
Secondary	Change in Pulmonary Artery Systolic Pressure	Change in Pulmonary Artery Systolic Pressure at 6 months, and 1 year over baseline	baseline, 6 months, 1 year
Secondary	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	6 months, 1 year
Secondary	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.	baseline, 30 days, 6 months, 1 year
Secondary	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.	baseline, 30 days, 6 months, 1 year
Secondary	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.	baseline, 6 months, 1 year, 2 year
Secondary	Change NT-pro-BNP Level	Change in NT-pro-BNP level at 6 months and 1 year and annually thereafter over baseline	baseline, 6 months, 1 year, 2 year
Secondary	Change in BNP Level	Change in BNP level at 6 months, 1 year and annually thereafter over baseline	baseline, 6 months, 1 year, 2 year
Secondary	Change in Tricuspid Regurgitation (TR) at 6 Months, 1 Year and Annually Thereafter Over Baseline	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.	6 months, 1 year, 2 year
Secondary	Change in Effective Regurgitant Orifice Area (EROA)	Change in effective regurgitant orifice area (EROA) at 30 days, 6 months, 1 year and annually thereafter over baseline.	baseline, 30 days, 6 months, 1 year, 2 year
Secondary	Change in Mitral Regurgitant Volume	Change in mitral regurgitant volume at 30 days, 6 months, 1 year and annually thereafter over baseline	baseline, 30 days, 6 months, 1 year, 2 year