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A Simplified Stepwise Approach to Echo Guidance during Percutaneous Mitral Valve Repair
Published on: October 16, 2021
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One-Year Outcomes From the CLASP IID Randomized Trial for Degenerative Mitral Regurgitation
Firas Zahr1, Robert L Smith2, Linda D Gillam3
1Oregon Health and Science University, Portland, Oregon, USA.
JACC. Cardiovascular Interventions
|November 14, 2023
Summary
The CLASP IID trial found the PASCAL system to be noninferior to the MitraClip system for treating degenerative mitral regurgitation in high-risk patients. Both devices showed sustained improvements in quality of life and function at one year.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Clinical Trials
Background:
- The CLASP IID trial is the first randomized controlled trial comparing the PASCAL Transcatheter Valve Repair System and the MitraClip System.
- It focuses on patients with prohibitive surgical risk and significant symptomatic degenerative mitral regurgitation (DMR).
Purpose of the Study:
- To report primary and secondary endpoints and one-year outcomes for the full cohort of the CLASP IID trial.
- To evaluate the safety and effectiveness of the PASCAL system compared to the MitraClip system.
Main Methods:
- Prohibitive-risk patients with severe DMR were randomized 2:1 to receive either the PASCAL system or the MitraClip system.
- One-year assessments included secondary effectiveness endpoints (mitral regurgitation severity), clinical, echocardiographic, functional, and quality-of-life outcomes.
- Primary safety (30-day composite major adverse events) and effectiveness (6-month MR ≤2+) endpoints were assessed.
Main Results:
- Three hundred patients were randomized; 204 received PASCAL and 96 received MitraClip.
- At one year, noninferiority was met for both primary and secondary effectiveness endpoints, with no significant differences in survival, heart failure hospitalization, or major adverse events between groups.
- Both systems demonstrated significant, sustained improvements in functional classification and quality of life compared to baseline.
Conclusions:
- The CLASP IID trial met its primary and secondary noninferiority endpoints.
- The PASCAL system demonstrated high survival, significant mitral regurgitation reduction, and sustained functional and quality-of-life benefits at one year.
- Results support the PASCAL system as an effective therapy for prohibitive-risk patients with symptomatic DMR.
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