Two-year outcomes of the MiCLASP post-market study

The MiCLASP post-market Study

The objective of this prospective, multicentre, single-arm, post-market clinical follow-up study is to evaluate the safety and effectiveness of the PASCAL system in patients with clinically significant symptomatic MR.

Two-year outcomes from the MiCLASP study confirm sustained safety and effectiveness of the PASCAL system in treating a broad population of FMR and DMR patients in a post-market setting.

Mitral regurgitation (MR) severity reduction

81%

of patients sustained MR ≤ 1+ at 2 years with the PASCAL system¹

Graph shows unpaired analysis. P values calculated from paired analysis relative to baseline using Wilcoxon signed rank test.

Core laboratory: Morristown Medical Center, Morristown NJ, USA.

Mitral regurgitation (MR) severity reduction

^abaseline vs. 2 years (n=228; MR≤1+=80.7%; MR≤2+=98.3%)

^bbaseline vs. 2 years (n=145; MR≤1+=82.8%; MR≤2+=98.6%)  

^cbaseline vs. 2 years (n=70; MR≤1+=75.7%; MR≤2+=97.1%)

New York Heart Association (NYHA) functional class

74%

of patients had achieved NYHA Class I/II at 2 years with the PASCAL system¹

Graph shows unpaired analysis. P values calculated from paired analysis relative to baseline using Wilcoxon signed rank test.

New York Heart Association (NYHA) functional class

^dbaseline vs. 2 years (n=286; NYHA class I/II=73.4%) 

^ebaseline vs. 2 years (n=175; NYHA class= I/II=71.4%) 

^fbaseline vs. 2 years (n=84; NYHA classI/II=77.4%)

Download results from the MiCLASP post market study and learn more about PASCAL Precision system:

MiCLASP study

Two-year outcomes of mitral transcatheter edge-to-edge repair from the MiCLASP study

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FMR: functional mitral regurgitation; DMR: degenerative mitral regurgitation

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References

T. Geisler, Two-year outcomes of mitral transcatheter edge-to-edge repair from the MiCLASP study. PCRLV 2024, The Top Late-Breaking Trials, 24th Nov. 2024

Medical device for professional use

For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).

Edwards, Edwards Lifesciences, the stylized E logo, CLASP, the CLASP logo, PASCAL, PASCAL Ace, and PASCAL Precision are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

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