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Two-year outcomes from the CLASP IID Registry

MICLASP study PASCAL - MR

CLASP IID Registry

The objective of this prospective, multicenter, multinational registry within the construct of the CLASP IID trial is to study significant symptomatic DMR patients at prohibitive surgical risk with complex mitral valve anatomy deemed suitable for treatment with the PASCAL system.

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Two-year outcomes from the CLASP IID Registry confirm the significant, sustained MR reduction, improved functional status and quality-of-life compared to baseline with the PASCAL system.

Baseline anatomical complexity distribution

15%

of patients met two anatomical complexity criteria

Baseline anatomical complexity distribution

aOther includes presence of significant cleft or perforation in the grasping area (6.2%), moderate to severe calcification in the grasping area (3.5%), leaflet mobility length <8 mm (3.5%), history of endocarditis and significant tissue defects in the leaflet (0.9%).

Mitral regurgitation (MR) severity reduction

92%

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

Graph shows unpaired analysis. MR severity assessed by TTE. P values relative to baseline were calculated using the Wilcoxon signed rank test.


Echocardiographic Core lab: Atlantic Health System Morristown Medical Center, Morristown NJ, USA.

Mitral regurgitation (MR) severity reduction

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

CLASP IID Registry

CLASP IID Registry

Longest follow up from the only prospective, CEC and core-lab adjudicated registry

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DMR, degenerative mitral regurgitation; MR, mitral regurgitation; TTE, Transthoracic echocardiography;

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References

  1. 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 service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

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