Pascal transcatheter mitral repair device performs as well as MitraClip in late-breaking CLASP IID Trial

Pascal vs. MitraClip CLASP IID trials details

The CLASP IID trial was a prospective, multicenter, international, randomized controlled trial to evaluate the safety and effectiveness of the Pascal transcatheter valve repair system compared with the MitraClip system in patients with significant symptomatic DMR.

Patients with 3+ or 4+ DMR at prohibitive surgical risk were considered for enrollment. Those who were deemed candidates for TEER with both systems were randomized to undergo treatment with the Pascal repair system or the MitraClip system at a 2:1 ratio.

The primary safety endpoint was a composite major adverse event (MAE) rate at 30 days including cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding and non-elective mitral valve re-intervention (either percutaneous or surgical) . Echocardiograms were collected at baseline, during the procedure, discharge and all follow-up visits of 30 days, six months and annually through five years.

The analysis was completed at 180 patients in an adaptive Bayesian design. Patients were randomized at 43 sites in the United States, Canada and Europe between November 2018 and December 2021 (117 Pascal, 63 MitraClip).

At 30 days, the rate of major adverse events was 3.4% for the Pascal system versus 4.8% for the MitraClip system (Difference -1.3%, 95% CI 5.1%).

The primary effectiveness endpoint was the proportion of patients with MR ≤2+ at six months (96.5% for Pascal versus 96.8% for MitraClip, Difference -0.3%, 95% CI -6.2%). In addition, patients in both treatment groups had significant improvements in functional and quality-of-life outcomes (p<0.05).

What is degenerative mitral regurgitation?

Severe DMR is associated with a poor prognosis, including a higher mortality rate, increased heart failure hospitalizations and impaired functional and quality-of-life outcomes. Medical therapy has a limited role and in the current guidelines, surgical mitral valve repair is recommended with proven efficacy and a well-established safety profile for DMR patients who are symptomatic and/or have impaired left ventricular systolic function.

It is believed that patients may be under treated due to high operative risk, under referral and aversion to surgery. In addition, transcatheter edge-to-edge repair with MitraClip may not be suitable or ideal for all anatomies, so patients need to undergo an imaging screening to assess their cardiac anatomy.

Disclosures: The study was funded by Edwards Lifesciences. Koulogiannis reported that he is a consultant and advisory board member for Edwards Lifesciences and a speaker for Abbott. Lim reported that he has received research grants from Abbott and Edwards Lifesciences.

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