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

January 16, 2026 updated by: Edwards Lifesciences
The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Chermside
      • Brisbane, Chermside, Australia, QLD 4032
        • Metro North Hospital & Health Service, The Prince Charles Hospital
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Sydney Local Health District, Royal Prince Alfred Hospital
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6E 1M7
        • St. Paul's Hospital, Providence Health Care Research Institute
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Hospital
      • Toronto, Ontario, Canada, M5B-1W8
        • St Michael Hospital
  • Germany
      • Bonn, Germany, 53127
        • Universitaetsklinikum Bonn, Medizinische Klinik II, Kardiologie
  • Greece
      • Athens, Greece, 15123
        • Hygeia Hospital
  • Italy
      • Milan, Italy, 20132
        • San Rafaelle Hospital
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital, University Hospital Bern
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Northshore University Healthsystem
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
    • Texas
      • Plano, Texas, United States, 75093
        • The Heart Hospital Baylor Plano
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Edwards PASCAL Transcatheter Mitral Valve Repair System
Device: Mitral Valve Repair
Minimal Invasive Transcatheter Mitral Valve Repair

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Exit from the cardiac catheterization laboratory
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.
30 days
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.
through discharge
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.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in LVEDV, Baseline to 6-Month Visit
Time Frame: Baseline and 6 Months
Change in left ventricular end diastolic volume (LVEDV) from the Baseline to the 6-Month visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 6 Months
Change in LVEDV, Baseline to 1-Year Visit
Time Frame: Baseline and 1 Year
Change in left ventricular end diastolic volume (LVEDV) from the Baseline to the 1-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 1 Year
Change in LVEDV, Baseline to 2-Year Visit
Time Frame: Baseline and 2 Years
Change in left ventricular end diastolic volume (LVEDV) from the Baseline to the 2-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 2 Years
Change in LVEDV, Baseline to 3-Year Visit
Time Frame: Baseline and 3 Years
Change in left ventricular end diastolic volume (LVEDV) from the Baseline to the 3-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 3 Years
Change in LVESV, Baseline to 6-Month Visit
Time Frame: Baseline and 6 Months
Change in left ventricular end systolic volume (LVESV) from the Baseline to the 6-Month visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 6 Months
Change in LVESV, Baseline to 1-Year Visit
Time Frame: Baseline and 1 Year
Change in left ventricular end systolic volume (LVESV) from the Baseline to the 1-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 1 Year
Change in LVESV, Baseline to 2-Year Visit
Time Frame: Baseline and 2 Years
Change in left ventricular end systolic volume (LVESV) from the Baseline to the 2-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 2 Years
Change in LVESV, Baseline to 3-Year Visit
Time Frame: Baseline and 3 Years
Change in left ventricular end systolic volume (LVESV) from the Baseline to the 3-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 3 Years
Change in PASP, Baseline to 6-Month Visit
Time Frame: Baseline and 6 Months
Change in pulmonary artery systolic pressure (PASP) from the Baseline to the 6-Month visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 6 Months
Change in PASP, Baseline to 1-Year Visit
Time Frame: Baseline and 1 Year
Change in pulmonary artery systolic pressure (PASP) from the Baseline to the 1-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 1 Year
Change in PASP, Baseline to 2-Year Visit
Time Frame: Baseline and 2 Years
Change in pulmonary artery systolic pressure (PASP) from the Baseline to the 2-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 2 Years
Change in PASP, Baseline to 3-Year Visit
Time Frame: Baseline and 3 Years
Change in pulmonary artery systolic pressure (PASP) from the Baseline to the 3-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 3 Years
6MWD by Study Visit
Time Frame: Baseline, 6 Months and 1 Year
Six-minute walk distance (6MWD) by study visit
Baseline, 6 Months and 1 Year
Change in 6MWD, Baseline to 6-Month Visit
Time Frame: Baseline and 6 Months
Change in 6-minute walk distance (6MWD) from the Baseline to the 6-Month visit
Baseline and 6 Months
Change in 6MWD, Baseline to 1-Year Visit
Time Frame: Baseline and 1 Year
Change 6-minute walk distance (6MWD) from the Baseline to the 1-Year visit
Baseline and 1 Year
KCCQ OS Score by Study Visit
Time Frame: Baseline, 30 Days, 6 Months and 1 Year
Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ OS) score by study visit. The KCCQ OS score is a validated measure summarizing a patient's overall health status based on their self-assessment of heart failure symptoms, physical limitations, social limitations, and quality of life on a 23-item, self-administered questionnaire. KCCQ OS scores range from 0 to 100, with higher scores indicating better health status.
Baseline, 30 Days, 6 Months and 1 Year
Change in KCCQ OS Score, Baseline to 30-Day Visit
Time Frame: Baseline and 30 Days
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ OS) Score from the Baseline to the 30-Day visit. The KCCQ OS score is a validated measure summarizing a patient's overall health status based on their self-assessment of heart failure symptoms, physical limitations, social limitations, and quality of life on a 23-item, self-administered questionnaire. KCCQ OS scores range from 0 to 100, with higher scores indicating better health status.
Baseline and 30 Days
Change in KCCQ OS Score, Baseline to 6-Month Visit
Time Frame: Baseline and 6 Months
Change in Kansas City Cardiomyopathy Overall Summary (KCCQ OS) score from the Baseline to the 6-Month visit. The KCCQ OS score is a validated measure summarizing a patient's overall health status based on their self-assessment of heart failure symptoms, physical limitations, social limitations, and quality of life on a 23-item, self-administered questionnaire. KCCQ OS scores range from 0 to 100, with higher scores indicating better health status.
Baseline and 6 Months
Change in KCCQ OS Score, Baseline to 1-Year Visit
Time Frame: Baseline and 1 Year
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ OS) score from the Baseline to the 1-Year visit. The KCCQ OS score is a validated measure summarizing a patient's overall health status based on their self-assessment of heart failure symptoms, physical limitations, social limitations, and quality of life on a 23-item, self-administered questionnaire. KCCQ OS scores range from 0 to 100, with higher scores indicating better health status.
Baseline and 1 Year
EQ5D VAS Score by Study Visit
Time Frame: Baseline, 30 Days, 6 Months and 1 Year
EQ5D visual analogue scale (VAS) score by study visit. The EQ5D is a validated, self-administered quality of life questionnaire including a VAS that records the respondent's self-rated health status on a graduated scale (0-100), with higher scores for higher health-related quality of life.
Baseline, 30 Days, 6 Months and 1 Year
Change in EQ5D VAS Score, Baseline to 30-Day Visit
Time Frame: Baseline and 30 Days
Change in EQ5D visual analogue scale (VAS) score from the Baseline to the 30-Day visit. The EQ5D is a validated, self-administered quality of life questionnaire including a VAS that records the respondent's self-rated health status on a graduated scale (0-100), with higher scores for higher health-related quality of life.
Baseline and 30 Days
Change in EQ5D VAS Score, Baseline to 6-Month Visit
Time Frame: Baseline and 6 Months
Change in EQ5D visual analogue scale (VAS) score from the Baseline to the 6-Month visit. The EQ5D is a validated, self-administered quality of life questionnaire including a VAS that records the respondent's self-rated health status on a graduated scale (0-100), with higher scores for higher health-related quality of life.
Baseline and 6 Months
Change in EQ5D VAS Score, Baseline to 1-Year Visit
Time Frame: Baseline and 1 Year
Change in EQ5D visual analogue scale (VAS) score from the Baseline to the 1-Year visit. The EQ5D is a validated, self-administered quality of life questionnaire including a VAS that records the respondent's self-rated health status on a graduated scale (0-100), with higher scores for higher health-related quality of life.
Baseline and 1 Year
Change in NT-proBNP, Baseline to 6-Month Visit
Time Frame: Baseline and 6 Months
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 6-Month visit
Baseline and 6 Months
Change in NT-proBNP, Baseline to 1-Year Visit
Time Frame: Baseline and 1 Year
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 1-Year visit
Baseline and 1 Year
Change in NT-proBNP, Baseline to 2-Year Visit
Time Frame: Baseline and 2 Years
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 2-Year visit
Baseline and 2 Years
Change in NT-proBNP, Baseline to 3-Year Visit
Time Frame: Baseline and 3 Years
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 3-Year visit
Baseline and 3 Years
Change in BNP, Baseline to 6-Month Visit
Time Frame: Baseline and 6 Months
Change in brain natriuretic peptide (BNP) level from the Baseline to the 6-Month visit
Baseline and 6 Months
Change BNP, Baseline to 1-Year Visit
Time Frame: Baseline and 1 Year
Change in brain natriuretic peptide (BNP) level from the Baseline to the 1-Year visit
Baseline and 1 Year
Change in BNP, Baseline to 2-Year Visit
Time Frame: Baseline and 2 Years
Change in brain natriuretic peptide (BNP) level from the Baseline to the 2-Year visit
Baseline and 2 Years
Change in BNP, Baseline to 3-Year Visit
Time Frame: Baseline and 3 Years
Change in brain natriuretic peptide (BNP) level from the Baseline to the 3-Year visit
Baseline and 3 Years
Change in Mitral EROA, Baseline to 30-Day Visit
Time Frame: Baseline and 30 Days
Change in mitral effective regurgitant orifice area (EROA) from the Baseline to the 30-Day visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 30 Days
Change in Mitral EROA, Baseline to 6-Month Visit
Time Frame: Baseline and 6 Months
Change in mitral effective regurgitant orifice area (EROA) from the Baseline to the 6-Month visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 6 Months
Change in Mitral EROA, Baseline to 1-Year Visit
Time Frame: Baseline and 1 Year
Change in mitral effective regurgitant orifice area (EROA) from the Baseline to the 1-Year visit, , measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 1 Year
Change in Mitral EROA, Baseline to 2-Year Visit
Time Frame: Baseline and 2 Years
Change in mitral effective regurgitant orifice area (EROA) from the Baseline to the 2-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 2 Years
Change in Mitral EROA, Baseline to 3-Year Visit
Time Frame: Baseline and 3 Years
Change in mitral effective regurgitant orifice area (EROA) from the Baseline to the 3-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 3 Years
Change in Mitral Regurgitant Volume, Baseline to 30-Day Visit
Time Frame: Baseline and 30 Days
Change in mitral regurgitant volume from the Baseline to the 30-Day visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 30 Days
Change in Mitral Regurgitant Volume, Baseline to 6-Month Visit
Time Frame: Baseline and 6 Months
Change in mitral regurgitant volume from the Baseline to the 6-Month visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 6 Months
Change in Mitral Regurgitant Volume, Baseline to 1-Year Visit
Time Frame: Baseline and 1 Year
Change in mitral regurgitant volume from the Baseline to the 1-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 1 Year
Change in Mitral Regurgitant Volume, Baseline to 2-Year Visit
Time Frame: Baseline and 2 Years
Change in mitral regurgitant volume from the Baseline to the 2-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 2 Years
Change in Mitral Regurgitant Volume, Baseline to 3-Year Visit
Time Frame: Baseline and 3 Years
Change in mitral regurgitant volume from the Baseline to the 3-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 3 Years
Mitral Regurgitation Reduction
Time Frame: Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Mitral regurgitation (MR) severity at 30 days, 6 months, 1 year and annually thereafter. Mitral regurgitation reduction was assessed by independent echocardiographic core laboratory review of transthoracic echocardiography (TTE) imaging.
Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
All-cause Mortality
Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 Years
All-cause mortality at 30 days, 6 months, 1 year and annually thereafter. The data are presented as cumulative deaths at each time point.
30 days, 6 months, 1 year, 2 years, 3 years, 4 Years
Recurrent Heart Failure Hospitalization
Time Frame: 30 days , 6 months, 1 year, 2 year, 3 year, 4 year
Recurrent heart failure hospitalization at 30 days, 6 months, 1 year and annually thereafter. The data are presented as cumulative heart failure hospitalizations at each time point.
30 days , 6 months, 1 year, 2 year, 3 year, 4 year
Reintervention Rates for Mitral Regurgitation
Time Frame: 30 days, 6 months, 1 year, 2 year, 3 year, 4 year
Reintervention rates for mitral regurgitation at 30 days, 6 months, 1 year and annually thereafter. The data are presented as cumulative reintervention rates at each time point.
30 days, 6 months, 1 year, 2 year, 3 year, 4 year
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.
Time Frame: 6 months, 1 year, 2 year, 3 year, 4 year
Composite of major adverse events (MAEs) 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. The outcome is analyzed as the count and percentage of participants with events at each timepoint.
6 months, 1 year, 2 year, 3 year, 4 year
LVEDV by Study Visit
Time Frame: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Left ventricular end diastolic volume (LVEDV) by study visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Change in LVEDV, Baseline to 4-Year Visit
Time Frame: Baseline and 4 Years
Change in left ventricular end diastolic volume (LVEDV) from the Baseline to the 4-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 4 Years
LVESV by Study Visit
Time Frame: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Left ventricular end systolic volume (LVESV) by study visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Change in LVESV, Baseline to 4-Year Visit
Time Frame: Baseline and 4 Years
Change in left ventricular end systolic volume (LVESV) from the Baseline to the 4-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 4 Years
PASP by Study Visit
Time Frame: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Pulmonary artery systolic pressure (PASP) by study visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Change in PASP, Baseline to 4-Year Visit
Time Frame: Baseline and 4 Years
Change in pulmonary artery systolic pressure (PASP) from the Baseline to the 4-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 4 Years
Change in NYHA Functional Classification
Time Frame: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
NYHA Functional Classification at 6 months, 1 year and annually thereafter. 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 Years, 3 Years, 4 Years
NT-proBNP by Study Visit
Time Frame: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
N-terminal pro-B-type natriuretic peptide (NT-proBNP) level by study visit.
Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Change in NT-proBNP, Baseline to 4-Year Visit
Time Frame: Baseline and 4 Years
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 4-Year visit
Baseline and 4 Years
BNP by Study Visit
Time Frame: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Brain natriuretic peptide (BNP) level by study visit
Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Change in BNP, Baseline to 4-Year Visit
Time Frame: Baseline and 4 Years
Change in brain natriuretic peptide (BNP) level from the Baseline to the 4-Year visit
Baseline and 4 Years
Change in Tricuspid Regurgitation From Baseline
Time Frame: 6 Month, 1 Year, 2 Years, 3 Years, 4 Years
Change in tricuspid regurgitation (TR) severity grade from the Baseline visit. TR severity was graded on a 5-point scale (none/trace, mild, mild-moderate, moderate-severe, severe) by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging.
6 Month, 1 Year, 2 Years, 3 Years, 4 Years
Mitral EROA by Study Visit
Time Frame: Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Mitral effective regurgitant orifice area (EROA) by study visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Change in Mitral EROA, Baseline to 4-Year Visit
Time Frame: Baseline and 4 Years
Change in mitral effective regurgitant orifice area (EROA) from the Baseline to the 4-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 4 Years
Mitral Regurgitant Volume by Study Visit
Time Frame: Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Mitral regurgitant volume by study visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Change in Mitral Regurgitant Volume, Baseline to 4-Year Visit
Time Frame: Baseline and 4 Years
Change in mitral regurgitant volume from the Baseline to the 4-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Baseline and 4 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Edwards Lifesciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gideon Cohen, MD, Sunnybrook Hospital
  • Principal Investigator: Ulrich Schafer, MD, Bundeswehrzentralkrankenhaus Koblenz
  • Principal Investigator: Molly Szerlip, MD, The Heart Hospital Baylor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 27, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Dietary Supplements

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