Results from the CLASP IID trial full cohort, presented Oct. 26 during TCT 2023 and simultaneously published in JACC: Cardiovascular Interventions, demonstrated noninferiority of mitral valve transcatheter edge-to-edge repair (M-TEER) using the PASCAL system compared with M-TEER using the MitraClip system in terms of safety and effectiveness in patients at prohibitive surgical risk and with significant symptomatic degenerative mitral regurgitation (DMR).

Firas Zahr, MD, FACC, et al., randomized 300 patients to either the PASCAL system (n=204) or the MitraClip system (n=96). The primary safety endpoint was a 30-day composite of major adverse events (MAE) and the primary effectiveness endpoints was six-months MR≤2+. At one year, researchers assessed the number of patients with MR≤2+ and MR≤1+, as well as clinical, echocardiographic, functional and quality-of-life outcomes.

Results found no significant difference at one year in survival, freedom from heart failure hospitalization and MAE (P>0.05 for all). Researchers noted that noninferiority of the PASCAL system compared with the MitraClip system persisted for the primary endpoints in the full cohort. Noninferiority was also met for the secondary effectiveness endpoints at one year [PASCAL vs. MitraClip; MR≤2+, 95.8% vs. 93.8%; rate difference, 2.1%; 95% LCB, -4.1% and MR≤1+, 77.1% vs. 71.3%; rate difference, 5.8%; 95% LCB, -5.3%, respectively]. Sustained significant improvements in functional classification and quality-of-life were observed in both groups.

"The Results affirm the PASCAL system as a beneficial therapy for prohibitive surgical risk patients with significant symptomatic DMR," said study investigators. In a related editorial, Jason H. Rogers, MD, FACC, agreed, adding that the "trial confirms the inherent strengths and weakness of the M-TEER approach in properly selected patients, which includes a high level of safety and also clinically meaningful but not complete MR elimination."

Meanwhile, in a second CLASP IID Registry study simultaneously published in JACC: Cardiovascular Interventions, Robert L. Smith, MD, FACC, et al., said their results demonstrate M-TEER using the PASCAL system is "safe and beneficial" in treating patients at high surgical risk, DMR and complex valve anatomy. One-year Kaplan-Meier estimates of freedom from composite MAEs, all-cause mortality and heart failure hospitalization were 83.5%, 89.3% and 91.5%, respectively. In addition, MR reduction was achieved at on year with improvements in related echocardiographic measures. New York Heart Association functional class and KCCO.

"At one year, treatment with the PASCAL system demonstrated safety and significant MR reduction, with continued improvement in clinical, echocardiographic, functional, and quality-of-life outcomes, illustrating the value of the PASCAL system in the treatment of prohibitive surgical risk patients with 3+ or 4+ DMR and complex mitral valve anatomy," said the study authors.