N/A
Completed N=124
The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
Mitral Valve Regurgitation
Source: ClinicalTrials.gov NCT03170349 ↗
Enrolled (actual)
124
Serious AEs
75.8%
Results posted
Dec 2021
Primary outcomePrimary: Number of Participants With Major Adverse Events (MAE) — 10 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Adverse Events (MAE) |
10 | — |
| PRIMARY Device Success |
175 | — |
| PRIMARY Number of Participants With Procedural Success |
115 | — |
| PRIMARY Clinical Success |
105 | — |
| SECONDARY Mitral Regurgitation Reduction |
0; 1; 0; 66; 57; 18 | — |
| SECONDARY All-cause Mortality |
1; 4; 10; 23; 31; 45 | — |
| SECONDARY Recurrent Heart Failure Hospitalization |
3; 10; 15; 23; 29; 33 | — |
| SECONDARY Reintervention Rates for Mitral Regurgitation |
1; 2; 2; 3; 4; 6 | — |
| SECONDARY 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. |
16; 23; 26; 33; 45 | — |
| SECONDARY LVEDV by Study Visit |
181.2; 166.2; 152.8; 145.9; 151.3; 141.2 | — |
| SECONDARY Change in LVEDV, Baseline to 6-Month Visit |
187.3; 169.9; -17.4 | — |
| SECONDARY Change in LVEDV, Baseline to 1-Year Visit |
178.0; 153.3; -24.6 | — |
| SECONDARY Change in LVEDV, Baseline to 2-Year Visit |
182.1; 153.0; -29.1 | — |
| SECONDARY Change in LVEDV, Baseline to 3-Year Visit |
187.6; 161.5; -26.1 | — |
| SECONDARY Change in LVEDV, Baseline to 4-Year Visit |
174.2; 147.6; -26.6 | — |
| SECONDARY LVESV by Study Visit |
108.7; 100.6; 91.1; 86.0; 91.9; 82.3 | — |
| SECONDARY Change in LVESV, Baseline to 6-Month Visit |
112.6; 103.2; -9.3 | — |
| SECONDARY Change in LVESV, Baseline to 1-Year Visit |
104.6; 90.8; -13.7 | — |
| SECONDARY Change in LVESV, Baseline to 2-Year Visit |
109.6; 91.6; -18.0 | — |
| SECONDARY Change in LVESV, Baseline to 3-Year Visit |
114.5; 100.2; -14.4 | — |
| SECONDARY Change in LVESV, Baseline to 4-Year Visit |
101.7; 88.1; -13.6 | — |
| SECONDARY PASP by Study Visit |
46.4; 39.7; 39.9; 37.2; 39.8; 39.6 | — |
| SECONDARY Change in PASP, Baseline to 6-Month Visit |
46.0; 40.2; -5.8 | — |
| SECONDARY Change in PASP, Baseline to 1-Year Visit |
46.4; 40.2; -6.2 | — |
| SECONDARY Change in PASP, Baseline to 2-Year Visit |
45.0; 38.0; -6.9 | — |
| SECONDARY Change in PASP, Baseline to 3-Year Visit |
44.2; 40.4; -3.8 | — |
| SECONDARY Change in PASP, Baseline to 4-Year Visit |
43.6; 40.7; -2.8 | — |
| SECONDARY 6MWD by Study Visit |
265.4; 290.8; 312.4 | — |
| SECONDARY Change in 6MWD, Baseline to 6-Month Visit |
273.2; 290.8; 17.6 | — |
| SECONDARY Change in 6MWD, Baseline to 1-Year Visit |
278.1; 312.4; 34.3 | — |
| SECONDARY Change in NYHA Functional Classification |
0; 49; 68; 6; 49; 52 | — |
| SECONDARY KCCQ OS Score by Study Visit |
54.6; 70.7; 71.7; 72.0 | — |
| SECONDARY Change in KCCQ OS Score, Baseline to 30-Day Visit |
54.6; 70.7; 16.0 | — |
| SECONDARY Change in KCCQ OS Score, Baseline to 6-Month Visit |
56.2; 71.7; 15.5 | — |
| SECONDARY Change in KCCQ OS Score, Baseline to 1-Year Visit |
56.1; 72.0; 15.9 | — |
| SECONDARY EQ5D VAS Score by Study Visit |
62.8; 74.3; 75.1; 73.4 | — |
| SECONDARY Change in EQ5D VAS Score, Baseline to 30-Day Visit |
62.4; 74.2; 11.8 | — |
| SECONDARY Change in EQ5D VAS Score, Baseline to 6-Month Visit |
63.9; 75.3; 11.5 | — |
| SECONDARY Change in EQ5D VAS Score, Baseline to 1-Year Visit |
64.2; 73.4; 9.2 | — |
| SECONDARY NT-proBNP by Study Visit |
4148.7; 2835.0; 2620.2; 2038.2; 2425.2; 1837.6 | — |
| SECONDARY Change in NT-proBNP, Baseline to 6-Month Visit |
3594.7; 2695.5; -899.2 | — |
| SECONDARY Change in NT-proBNP, Baseline to 1-Year Visit |
3450.8; 2129.2; -1321.6 | — |
| SECONDARY Change in NT-proBNP, Baseline to 2-Year Visit |
2505.9; 1313.1; -1192.8 | — |
| SECONDARY Change in NT-proBNP, Baseline to 3-Year Visit |
2802.4; 2513.6; -288.8 | — |
| SECONDARY Change in NT-proBNP, Baseline to 4-Year Visit |
2239.8; 1489.4; -750.4 | — |
| SECONDARY BNP by Study Visit |
839.5; 588.0; 569.3; 472.4; 500.0; 451.3 | — |
| SECONDARY Change in BNP, Baseline to 6-Month Visit |
813.5; 606.6; -206.9 | — |
| SECONDARY Change BNP, Baseline to 1-Year Visit |
746.7; 585.4; -161.3 | — |
| SECONDARY Change in BNP, Baseline to 2-Year Visit |
720.6; 470.8; -249.8 | — |
| SECONDARY Change in BNP, Baseline to 3-Year Visit |
744.2; 510.4; -233.9 | — |
| SECONDARY Change in BNP, Baseline to 4-Year Visit |
602.3; 458.3; -144.0 | — |
| SECONDARY Change in Tricuspid Regurgitation From Baseline |
0; 1; 14; 58; 35; 1 | — |
| SECONDARY Mitral EROA by Study Visit |
0.38; 0.17; 0.15; 0.18; 0.19; 0.24 | — |
| SECONDARY Change in Mitral EROA, Baseline to 30-Day Visit |
0.40; 0.17; -0.24 | — |
| SECONDARY Change in Mitral EROA, Baseline to 6-Month Visit |
0.40; 0.14; -0.27 | — |
| SECONDARY Change in Mitral EROA, Baseline to 1-Year Visit |
0.41; 0.18; -0.22 | — |
| SECONDARY Change in Mitral EROA, Baseline to 2-Year Visit |
0.35; 0.19; -0.16 | — |
| SECONDARY Change in Mitral EROA, Baseline to 3-Year Visit |
0.36; 0.25; -0.11 | — |
| SECONDARY Change in Mitral EROA, Baseline to 4-Year Visit |
0.44; 0.28; -0.16 | — |
| SECONDARY Mitral Regurgitant Volume by Study Visit |
57.3; 25.2; 25.3; 30.1; 31.0; 38.0 | — |
| SECONDARY Change in Mitral Regurgitant Volume, Baseline to 30-Day Visit |
62.5; 24.3; -38.2 | — |
| SECONDARY Change in Mitral Regurgitant Volume, Baseline to 6-Month Visit |
62.8; 22.8; -40.0 | — |
| SECONDARY Change in Mitral Regurgitant Volume, Baseline to 1-Year Visit |
61.5; 30.3; -31.2 | — |
| SECONDARY Change in Mitral Regurgitant Volume, Baseline to 2-Year Visit |
54.6; 31.0; -23.5 | — |
| SECONDARY Change in Mitral Regurgitant Volume, Baseline to 3-Year Visit |
59.9; 40.1; -19.8 | — |
| SECONDARY Change in Mitral Regurgitant Volume, Baseline to 4-Year Visit |
74.2; 41.7; -32.5 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03170349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.