Valvular & structural heart diseaseRandomised controlled trial
CLASP IID Trial and Registry
- Randomised controlled trial with concurrent registry (2-year follow-up)
- randomized 2:1
- nonrandomized registry for complex anatomy
Authors' conclusion
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.
Study context
- Population
- Prohibitive-risk patients with 3+/4+ degenerative mitral regurgitation (DMR)
- Participants
- 204 / 96 / 98
- Comparison
- PASCAL vs MitraClip transcatheter mitral valve repair
- PASCALn = 204
- MitraClipn = 96reference
- Registryn = 98
Primary result
As reported in the abstract
MR ≤2+ and MR ≤1+ (randomized cohort) · 2 years
| Group | Value | MR ≤1+ |
|---|---|---|
| PASCAL | 95.0% | 77.2% (78/101) |
| MitraClip | 91.5% | 67.8% (40/59) |
- PASCAL vs MitraClip: P = 0.500 — MR ≤2+
- PASCAL vs MitraClip: P = 0.198 — MR ≤1+
Further findings
| Outcome | PASCAL | MitraClip | Registry | P value |
|---|---|---|---|---|
| Freedom from all-cause mortality, CV mortality, HF hospitalization, nonelective mitral valve reintervention (Kaplan-Meier, randomized cohort) · 2 years | ||||
| All-cause mortality | 80.8% | 86.2% | Not reported in the abstract | P = 0.216 |
| CV mortality | 88.6% | 90.4% | Not reported in the abstract | P = 0.666 |
| HF hospitalization | 86.4% | 94.3% | Not reported in the abstract | P = 0.058 |
| Reintervention | 97.9% | 97.9% | Not reported in the abstract | P = 0.962 |
- Registry cohort: MR reduction and Kaplan-Meier freedom from events · 2 years
- 91.9% (34/37) · MR ≤2+ · MR ≤1+ 64.9% (24/37) · Freedom from all-cause mortality 77.2% · Freedom from CV mortality 84.0% · Freedom from HF hospitalization 85.1% · Freedom from reintervention 99.0%
Functional status and quality of life
- Significant improvements in both cohorts
Original publication
CLASP IID Trial and Registry. JACC Cardiovasc Interv. Published 13 October 2025. doi:10.1016/j.jcin.2025.07.014
Summarised from the published abstract; every number is checked against it