CLASP IID Trial and Registry: 2-Year Outcomes of Transcatheter Repair for Degenerative Mitral Regurgitation
Recommended Citation
Makkar R, Zahr F, Chakravarty T, Chadderdon S, Makar M, Ruf TF, Kipperman RM, Rassi AN, Hausleiter J, Smith RL, Szerlip M, Goldman S, Lim DS, Inglessis-Azuaje I, Yadav P, Lurz P, Kister T, Davidson CJ, Mumtaz M, Gada H, Kar S, Kodali SK, Laham R, Hiesinger W, Fam NP, Keßler M, O'Neill WW, Whisenant B, Kliger C, Rudolph V, Hermiller J, Dhoble A, Smalling R, Latib A, Lazkani M, Choo J, Garcia S, Rodés-Cabau J, Schofer N, Baldus S, Kapadia S, Koulogiannis K, Marcoff L, Gillam LD, and von Bardeleben RS. CLASP IID Trial and Registry: 2-Year Outcomes of Transcatheter Repair for Degenerative Mitral Regurgitation. JACC Cardiovasc Interv 2025;18(19):2392-2404.
Document Type
Article
Publication Date
10-13-2025
Publication Title
JACC Cardiovasc Interv
Keywords
Humans, Registries, Mitral Valve Insufficiency, Male, Female, Mitral Valve, Time Factors, Heart Valve Prosthesis Implantation, Aged, Heart Valve Prosthesis, Risk Factors, Treatment Outcome, Cardiac Catheterization, Aged, 80 and over, Recovery of Function, Prosthesis Design
Abstract
BACKGROUND: One-year outcomes from the CLASP IID Trial (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial; NCT03706833) and Registry established the PASCAL transcatheter valve repair system as a safe and effective treatment for prohibitive-risk degenerative mitral regurgitation (DMR). Longer-term follow-up is ongoing.
OBJECTIVES: This paper reports the CLASP IID Trial and Registry 2-year outcomes.
METHODS: In the CLASP IID Trial, prohibitive-risk patients with 3+/4+ DMR, deemed suitable for both the PASCAL and MitraClip systems, were randomized 2:1 (PASCAL: n = 204; MitraClip: n = 96). Patients with complex anatomy deemed ineligible for randomization were enrolled in the CLASP IID Registry (N = 98) and treated with the PASCAL system.
RESULTS: In the randomized cohort, significant and sustained MR reduction was achieved at 2 years. MR ≤2+ rate was 95.0% (96/101) in the PASCAL group vs 91.5% (54/59) in the MitraClip group (P = 0.500), and MR ≤1+ rate was 77.2% (78/101) vs 67.8% (40/59) (P = 0.198), respectively. Kaplan-Meier estimates for freedom from all-cause mortality, cardiovascular mortality, heart failure hospitalization, and nonelective mitral valve reinterventions were 80.8% vs 86.2% (P = 0.216), 88.6% vs 90.4% (P = 0.666), 86.4% vs 94.3% (P = 0.058), and 97.9% vs 97.9% (P = 0.962), respectively. In the registry cohort, 91.9% (34/37) achieved MR ≤2+ and 64.9% (24/37) achieved MR ≤1+. Kaplan-Meier estimates for freedom from all-cause mortality, cardiovascular mortality, heart failure hospitalization, and nonelective mitral valve reinterventions were 77.2%, 84.0%, 85.1%, and 99.0%, respectively. Significant improvements in functional status and quality of life were observed in both cohorts.
CONCLUSIONS: Two-year outcomes from the CLASP IID Trial and Registry show favorable survival, and significant and sustained MR reduction with functional and quality-of-life improvements, confirming sustained safety and effectiveness of the PASCAL system in treating a broad population of DMR patients.
Medical Subject Headings
Humans; Registries; Mitral Valve Insufficiency; Male; Female; Mitral Valve; Time Factors; Heart Valve Prosthesis Implantation; Aged; Heart Valve Prosthesis; Risk Factors; Treatment Outcome; Cardiac Catheterization; Aged, 80 and over; Recovery of Function; Prosthesis Design
PubMed ID
41093456
Volume
18
Issue
19
First Page
2392
Last Page
2404
