The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study (CLASP)
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| ClinicalTrials.gov Identifier: NCT03170349 |
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Recruitment Status :
Active, not recruiting
First Posted : May 31, 2017
Results First Posted : December 1, 2021
Last Update Posted : August 23, 2022
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Sponsor:
Edwards Lifesciences
Information provided by (Responsible Party):
Edwards Lifesciences
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Mitral Valve Regurgitation | Device: Mitral Valve Repair | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 124 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study |
| Actual Study Start Date : | June 27, 2017 |
| Actual Primary Completion Date : | July 30, 2020 |
| Estimated Study Completion Date : | August 2025 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Edwards PASCAL Transcatheter Mitral Valve Repair System |
Device: Mitral Valve Repair
Minimal Invasive Transcatheter Mitral Valve Repair |
Primary Outcome Measures :
- 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
- 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.
- Number of Participants With Procedural Success [ Time Frame: through discharge ]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.
- Clinical Success [ Time Frame: 30 days ]Procedural success with evidence of MR reduction ≤ MR2+ and without MAEs at 30 days. Mitral regurgitation reduction was assessed per independent echocardiography core laboratory.
Secondary Outcome Measures :
- Mitral Regurgitation Reduction [ Time Frame: baseline, 30 days, 6 months, 1 year ]Mitral regurgitation reduction at 30 days, 6 months, and 1 year over baseline. Mitral regurgitation reduction was assessed per independent echocardiography core laboratory.
- All-cause Mortality [ Time Frame: 30 days, 6 months, 1 year ]All-cause mortality at 30 days, 6 months, 1 year
- Recurrent Heart Failure Hospitalization [ Time Frame: 30 days , 6 months, 1 year ]Recurrent heart failure hospitalization at 30 days, 6 months, 1 year
- Re-intervention Rates for Mitral Regurgitation [ Time Frame: 30 days, 6 months and 1 year ]Re-intervention rates for mitral regurgitation at 30 days, 6 months, 1 year
- 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 [ Time Frame: 6 months, 1 year ]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
- Change in Left Ventricular End Diastolic Volume (LVEDV) [ Time Frame: 6 months, 1 year ]Change in Left Ventricular End Diastolic Volume (LVEDV) at 6 months, and 1 year over baseline
- Change in Left Ventricular End Systolic Volume (LVESV) [ Time Frame: 6 months, 1 year ]Change in Left Ventricular End Systolic Volume (LVESV) at 6 months and 1 year over baseline
- Change in Pulmonary Artery Systolic Pressure [ Time Frame: baseline, 6 months, 1 year ]Change in Pulmonary Artery Systolic Pressure at 6 months, and 1 year over baseline
- Change in Six Minute Walk Test (6MWT) Distance [ Time Frame: 6 months, 1 year ]Mean distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months, and 1 year compared to baseline
- Change in Quality of Life (QoL) Score, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: baseline, 30 days, 6 months, 1 year ]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.
- Change in Quality of Life (QoL) Score, as Measured by EQ5D [ Time Frame: baseline, 30 days, 6 months, 1 year ]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.
- Change in NYHA Functional Classification [ Time Frame: baseline, 6 months, 1 year ]
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.
- Change NT-pro-BNP Level [ Time Frame: baseline, 6 months, 1 year ]Change in NT-pro-BNP level at 6 months and 1 year over baseline
- Change in BNP Level [ Time Frame: baseline, 6 months, 1 year ]Change in BNP level at 6 months over baseline
- Change in Tricuspid Regurgitation (TR) [ Time Frame: 6 months, 1 year ]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.
- Change in Effective Regurgitant Orifice Area (EROA) [ Time Frame: baseline, 30 days, 6 months, 1 year ]Change in effective regurgitant orifice area (EROA) at 30 days, 6 months, and 1 year over baseline
- Change in Mitral Regurgitant Volume [ Time Frame: baseline, 30 days, 6 months, 1 year ]Change in mitral regurgitant volume at 30 days, 6 months and 1 year over baseline
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170349
Locations
Show 17 study locations
Sponsors and Collaborators
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 |
Study Documents (Full-Text)
Documents provided by Edwards Lifesciences:
Documents provided by Edwards Lifesciences:
Study Protocol [PDF] August 20, 2018
Statistical Analysis Plan [PDF] August 21, 2018
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Edwards Lifesciences |
| ClinicalTrials.gov Identifier: | NCT03170349 |
| Other Study ID Numbers: |
2016-05 |
| First Posted: | May 31, 2017 Key Record Dates |
| Results First Posted: | December 1, 2021 |
| Last Update Posted: | August 23, 2022 |
| Last Verified: | July 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes |
| Product Manufactured in and Exported from the U.S.: | Yes |
Additional relevant MeSH terms:
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Mitral Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases |