Two-year results from the CLASP IID Randomized Trial and Registry confirm the sustained safety and effectiveness of the PASCAL system in treating a broad population of degenerative mitral regurgitation (DMR) patients. These results were presented by Firas Zahr, MD, of the Oregon Health & Science University, Portland, on behalf of the CLASP IID Trial and Registry Investigators in a late-breaking trial session at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 meeting on Wednesday. The CLASP IID trial, conducted at 54 sites across the United States, Canada and Europe, enrolled 300 patients (mean age 81 year, 35% women) with significant symptomatic DMR graded as MR 3+ or 4+. All patients were at prohibitive surgical risk and considered suitable for either device, and they were randomized 2:1 to receive either the Pascal or MitraClip device. The trial's primary endpoints included the rate of major adverse events at 30 days (for safety) and the proportion of patients with MR graded as 2+ or lower at 6 months (for efficacy). Results showed Pascal to be noninferior to MitraClip. At the extended 2-year follow-up, both Pascal and MitraClip showed low mortality and heart failure hospitalization rates, sustained improvements in MR, echocardiographic measures, NYHA functional status, and quality of life, mirroring findings from earlier 6-month and 1-year analyses. MR reduction to grade ≤1 was achieved in 78.8% of Pascal patients compared to 68.5% of MitraClip patients (P=0.12), and MR ≤2 was maintained in 94.9% versus 93.2%, respectively (P=0.75). NYHA class I or II was seen in 88.2% of Pascal patients versus 88.0% of MitraClip patients (P=1.0) and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores improved by 16.9 and 12.7 points, respectively (P=0.77). At the 2-year follow-up, secondary endpoints included all-cause mortality, heart failure hospitalizations, non-elective mitral valve reintervention and quality of life. Results showed freedom from all-cause mortality at 80.8% for Pascal versus 86.2% for MitraClip (p=0.22), freedom from cardiovascular mortality at 88.6% versus 90.4% (p=0.67), freedom from heart failure hospitalization at 86.4% versus 94.3% (p=0.06) and freedom from non-elective mitral valve reintervention at 97.9% for both devices (p=0.96). In the CLASP IID Registry, which included patients with a wide range of mitral valve anatomies unsuitable for randomization and treated with the Pascal system, favorable outcomes were also observed, including 83.7% in NYHA class 1 or 2 and 12.3 improvement in KCCQ overall summary score. Overall, the CLASP IID trial confirmed the safety and efficacy of M-TEER for DMR patients. Image Caption: Firas Zahr, MD, speaks during a news conference Wednesday at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, DC. Image Credit: Bailey G. Salimes, CRTonline.org