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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03170349
Other study ID # 2016-05
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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