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PASCAL System Demonstrates Noninferiority to MitraClip for DMR in CLASP IID Trial

Just days removed from receiving approval from the US Food and Drug Administration, new data from the CLASP IID trial is providing clinicians with an overview of the effects of the PASCAL transcatheter edge-to-edge repair (TEER) system against another contemporary TEER therapy for patients with degenerative mitral regurgitation (DMR).

Designed to assess the safety and effectiveness of the PASCAL system compared to the MitraClip system in patients with significant symptomatic DMR, results of the prespecified interim analysis of the CLASP IID trial demonstrate the Pascal TEER system met the study’s noninferiority endpoints, which included a composite of major adverse event rate at 30 days and the proportion of patients with grade 2+ mitral regurgitation at 6 months.

"The CLASP IID randomized trial further establishes the PASCAL system as a safe and effective therapy, expanding the armamentarium of transcatheter mitral valve treatment options for patients with DMR," said principal investigator Scott Lim, MD, director of the Advanced Heart Valve Center at University of Virginia Health System, in a statement from Edwards Lifesciences. "Several distinct design characteristics of the PASCAL system, including the flexible nitinol design and elongation capability, contribute to the positive outcomes of this study."

Presented at TCT 2022, the 34th annual scientific symposium of the Cardiovascular Research Foundation, the CLASP IID randomized trial was launched in 2018 with the intent of comparing the PASCAL system against the MitraClip in individuals with DMR considered ineligible for mitral valve surgery. Enrolling individuals from 43 sites across North America and Europe and randomizing them in a 2:1 ratio to receive the PASAL system or the MitraClip system, the trial is designed to include up to 300 patients with follow-up visits planned at discharge, 30 days, 6 months, and annually through 5 years, which included echocardiographic assessments. Based on American Society of Echocardiography guidelines and mitral regurgitation severity, mitral regurgitation was graded on a scale of 0 to 4+.

In the interim analysis presented at TCT, Lim presented data related to 170 patients. The primary safety endpoint of interest for the analysis was a composite major adverse event rate at 30 days, which was defined as cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding, and nonelective mitral valve reintervention. The primary efficacy endpoint of interest for the analysis was the portion of patients with mitral regurgitation of grade 2+.

In the TCT 2022 presentation, results indicated the PASCAL system demonstrated noninferiority compared to the MitraClip system for the primary safety endpoint, with major adverse event rates of 3.4% and 4.8%, respectively. The PASCAL system also demonstrated noninferiority for the primary efficacy endpoint, with 96.5% and 96.8% of patients achieving mitral regurgitation grade of 2+ or less, respectively.

Further analysis pointed to significant improvements in both functional and quality of life outcomes for both groups. Additionally, investigators pointed out the portion of patients with a mitral regurgitation graded 1+ or less was durable in the PASCAL group from discharge to 6 months, with rates of 87.2% and 83.7% (P=.317 vs discharge), respectively for the PASCAL system group compared with 88.5% and 71.2% (P=.003 vs discharge), respectively, for the MitraClip system group.

"As we consider the many DMR patients who are suffering with debilitating symptoms and could benefit from a TEER procedure, we are very pleased with the outcomes from the CLASP IID trial," added Bernard J. Zovighian, Edwards' corporate vice president, transcatheter mitral and tricuspid therapies at Edwards Lifesciences, in the aforementioned statement "Edwards continues to prioritize evidence generation with world-class data in support of our patient-driven therapies, and we are proud to support this and multiple other pivotal trials as we work to transform treatment for these patients in need."

This study, “Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients,” was presented at TCT 2022 and simultaneously published in JACC: Interventions.