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Published on: October 16, 2021
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.
Insights
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.
Background:
The CLASP IID (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical) trial is the first randomized controlled trial comparing the PASCAL system and the MitraClip system in prohibitive risk patients with significant symptomatic degenerative mitral regurgitation (DMR).
Objectives:
The study sought to report primary and secondary endpoints and 1-year outcomes for the full cohort of the CLASP IID trial.
Methods:
Prohibitive-risk patients with 3+/4+ DMR were randomized 2:1 (PASCAL:MitraClip). One-year assessments included secondary effectiveness endpoints (mitral regurgitation [MR] ≤2+ and MR ≤1+), and clinical, echocardiographic, functional, and quality-of-life outcomes. Primary safety (30-day composite major adverse events [MAE]) and effectiveness (6-month MR ≤2+) endpoints were assessed for the full cohort.
Results:
Three hundred patients were randomized (PASCAL: n = 204; MitraClip: n = 96). At 1 year, differences in survival, freedom from heart failure hospitalization, and MAE were nonsignificant (P > 0.05 for all). Noninferiority of the PASCAL system compared with the MitraClip system persisted for the primary endpoints in the full cohort (For PASCAL vs MitraClip, the 30-day MAE rates were 4.6% vs 5.4% with a rate difference of -0.8% and 95% upper confidence bound of 4.6%. The 6-month MR≤2+ rates were 97.9% vs 95.7% with a rate difference of 2.2% and 95% lower confidence bound (LCB) of -2.5%, for, respectively). Noninferiority was met for the secondary effectiveness endpoints at 1 year (MR≤2+ rates for PASCAL vs MitraClip were 95.8% vs 93.8% with a rate difference of 2.1% and 95% LCB of -4.1%. The MR≤1+ rates were 77.1% vs 71.3% with a rate difference of 5.8% and 95% LCB of -5.3%, respectively). Significant improvements in functional classification and quality of life were sustained in both groups (P <0.05 for all vs baseline).
Conclusions:
The CLASP IID trial full cohort met primary and secondary noninferiority endpoints, and at 1 year, the PASCAL system demonstrated high survival, significant MR reduction, and sustained improvements in functional and quality-of-life outcomes. Results affirm the PASCAL system as a beneficial therapy for prohibitive-surgical-risk patients with significant symptomatic DMR.
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