- The MitraClip system has been established as a robust platform for transcatheter repair of both degenerative and functional mitral regurgitation. However, it has not been compared against more novel therapies (such as the PASCAL system). The CLASP IID trial is the first RCT to directly compare two transcatheter valve repair therapies for degenerative MR.
- The PASCAL system met the primary safety and effectiveness endpoints of this pivotal noninferiority trial. There was a low composite MAE rate (3.4%) at 30 days, and 97.7% of patients achieved sustained reduction of MR (≤ 2+) at 6 months.
- This trial establishes the PASCAL system as a safe, beneficial therapy for patients with significant symptomatic DMR and prohibitive surgical risk.
The MitraClip system has been used in both degenerative and functional mitral regurgitation in patients at prohibitive risk of cardiac surgery. However, the utility of more novel methods in comparison, such as the PASCAL transcatheter repair system, has not yet been established. In a breaking presentation at the 2022 TCT Conference today, Dr. Scott Lim (University of Virginia), Dr. Konstantinos Koulogiannis (Atlantic Health System Morristown Medical Center) and their team presented their study: “A Randomized Comparison of Transcatheter Edge to Edge Repair Devices for Degenerative Mitral Regurgitation Clinical Outcomes and Echo Findings,” or the CLASP IID Study.
The CLASP IID study (NCT03706833) was a prospective, multicenter, randomized controlled pivotal trial conducted across 93 centers in North America and Europe. The study aimed to establish the safety and effectiveness of the Edwards PASCAL system in the repair of degenerative mitral regurgitation (DMR) as compared with the MitraClip. The inclusion criteria comprised adults with 3-4+ degenerative mitral regurgitation who were felt to be at prohibitive risk of mitral valve surgery; relevant exclusions included contraindication to TEE, refractory Stage D heart failure, recent stroke, or other severe valve disorders requiring intervention. A total of 180 patients were randomized at a 2:1 ratio in which 117 received a PASCAL device and 63 received a MitraClip.
The primary safety endpoint was a composite of major adverse events (MAE) at 30 days which was assessed via a non-inferiority analysis; this safety endpoint was met, with a composite event rate of 3.4% with PASCAL and 4.8% for MitraClip. The primary non-inferiority effectiveness outcome was the number of patients experiencing ≤ 2+ MR at 6 months. The proportion of patients with MR ≤2+ at 6 months was 96.5% for the PASCAL group and 96.8% for the MitraClip group. Additionally, at 6 months, the proportion of patients with sustained MR ≤1+ in the PASCAL group at 83.7% vs 71.2% in the MitraClip group.
When discussing the clinical implications of the study at TCT, the authors stated: “The CLASP IID trial is the first RCT to directly compare two contemporary TEER therapies…and met its primary safety and effectiveness endpoints…The PASCAL system is a beneficial therapy for significant symptomatic degenerative mitral regurgitation, expanding transcatheter treatment options for prohibitive surgical risk patients.”