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

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: Completed
• Conditions: Mitral Valve Regurgitation
• Intervention / Treatment: Device: Mitral Valve Repair

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: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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
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 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	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	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

Outcome Measure	Measure Description	Time Frame
Change in LVEDV, Baseline to 6-Month Visit	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	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	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	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	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	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	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	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	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	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	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	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	Six-minute walk distance (6MWD) by study visit	Baseline, 6 Months and 1 Year
Change in 6MWD, Baseline to 6-Month Visit	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	Change 6-minute walk distance (6MWD) from the Baseline to the 1-Year visit	Baseline and 1 Year
KCCQ OS Score by Study Visit	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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.	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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

• Sponsor: Edwards Lifesciences
• Investigators: 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

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2017
• Primary Completion (Actual): July 30, 2020
• Study Completion (Actual): May 27, 2025

Study Registration Dates

• First Submitted: May 26, 2017
• First Submitted That Met QC Criteria: May 26, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency; Surgical Procedures, Operative; Cardiovascular Surgical Procedures; Cardiac Surgical Procedures; Thoracic Surgical Procedures; Cardiac Valve Annuloplasty; Mitral Valve Annuloplasty
• Other Study ID 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