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Completed

NCT Number: NCT03170349

The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.

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Key information

Conditions

Mitral Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Metro North Hospital & Health Service, The Prince Charles Hospital, Brisbane, Chermside, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mitral valve repair

Device

Minimal Invasive Transcatheter Mitral Valve Repair

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 6MWD by Study Visit

    Time frame: Baseline, 6 Months and 1 Year

    Six-minute walk distance (6MWD) by study visit

  25. 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

  26. 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

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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

  38. 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

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

  44. 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

  45. 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

  46. 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

  47. 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

  48. 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.

  49. 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

  50. 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

  51. 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

  52. 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

  53. 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

  54. 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

  55. 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

  56. 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

  57. 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

  58. 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

  59. 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

  60. 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

  61. 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

  62. 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

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Acronym: CLASP

Important dates

Study start
2017
Primary completion
2020
Study completion
2025
First posted
May 31, 2017
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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