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Two-year results of CLASP IID randomized trial

MICLASP study PASCAL - MR

CLASP IID trial

The objective of this prospective, multicenter, multinational, randomized, controlled pivotal trial is to evaluate safety and effectiveness of the PASCAL transcatheter valve repair system compared to the MitraClip system, in patients with significant symptomatic degenerative mitral regurgitation (DMR) who were determined to be at prohibitive risk for mitral valve surgery by the local heart team.¹

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Two-year results from the CLASP IID randomized trial confirm the sustained safety and effectiveness of the PASCAL system in treating a prohibitive-surgical-risk DMR patients.2

Mitral regurgitation (MR) severity reduction

79%

of patients sustained MR ≤ 1+ at 2 years with the PASCAL system2

Graph shows unpaired analysis. MR severity assessed by TTE. P values relative to baseline were calculated using the Wilcoxon singed rank test and P values between treatment groups were calculated from Fisher’s exact test.

Echocardiographic Core lab: Atlantic Health System Morristown Medical Center, Morristown NJ, USA.
Mitral-regurgitation-severity-reduction-Desktop

Freedom from cardiovascular mortality

89%

freedom from cardiovascular mortality at 2 years with the PASCAL system2

Graph shows Kaplan-Meier analysis time to first event (KM estimate + SE) and error bars represent 95% CI. 
Freedom from cardiovascular mortality desktop

Freedom from heart failure hospitalization (HFH)

86%

freedom from HFH at 2 years with the PASCAL system2

Graph shows Kaplan-Meier analysis time to first event (KM estimate + SE) and error bars represent 95% CI. 
Freedom from heart failure hospitalization desktop

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

CLASP IID

CLASP IID

Two-year results from the CLASP IID randomized trial

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CV: cardiovascular, DMR: degenerative mitral regurgitation, HFH: heart failure hospitalization, MR: mitral regurgitation, TEER: transcatheter edge-to-edge repair, TTE: transthoracic echocardiography, USA: United States of America.

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References

  1. Zahr F, et al. One-year Outcomes from the CLASP IID Randomized Trial for Degenerative Mitral Regurgitation. JACC Cardiovasc Interv. 2023;16(23):2803-2816
  2. Zahr F, et al. CLASP IID Randomized Trial and Registry: Two-Year Outcomes of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation. Presented at: TCT Annual Congress; 2024 Oct 30; Washington, DC.
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, CLASP II, the CLASP logo, PASCAL, PASCAL Ace, and PASCAL Precision are trademarks or services marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

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