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One-year outcomes of the TriCLASP post-market study

MICLASP study PASCAL - TR

The TriCLASP 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 symptomatic, severe or greater TR, in a European post-market setting.¹

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One-year outcomes from the TriCLASP study confirm sustained safety and effectiveness of the PASCAL system in patients with clinically significant TR in a post-market setting.

Tricuspid Regurgitation (TR) severity reduction

87%

of patients with TR≤2+ at 1 year with the PASCAL system1

Graph shows unpaired analysis.

Core laboratory: Cardialysis, Rotterdam, The Netherlands

Tricuspid Regurgitation (TR) severity reduction

aWilcoxon signed-rank test for moderate or less TR, paired analysis
bn=269; baseline=23.8%; discharge=87.4%
cn=187; baseline=28.3%; 1 year 87.7%

New York Heart Association (NYHA) functional class

75%

of patients had achieved NYHA Class I/II at 1-year with the PASCAL system1

Graph shows paired analysis and error bars indicate 95% Cl. 
New York Heart Association (NYHA) functional class

aWilcoxon Signed Rank Test, paired analysis

Download the clinical data insert and learn more about PASCAL Precision system:

TriCLASP Study thumbnail

TriCLASP Study

One-year outcomes of the TriCLASP post-market study

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TR: tricuspid regurgitation; NYHA: New York Heart Association

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References

  1. J. Hausleiter. Transcatheter Tricuspid Valve Repair: TriCLASP Study 1-Year Results. PCRLV 2024, Tricuspid Hotline. 25th Nov. 2024.
Medical device for professional use

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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