Key Points from this trial:

The CLASP IID trial, the first randomized controlled trial comparing the PASCAL system and the MitraClip system in prohibitive-risk patients with significant symptomatic degenerative mitral regurgitation (DMR), aimed to report primary and secondary endpoints along with 1-year outcomes for the full cohort.

In the study, 300 patients were randomized (PASCAL: n = 204; MitraClip: n = 96).

At 1 year, differences in survival, freedom from heart failure hospitalization, and major adverse events (MAE) were nonsignificant (P > 0.05 for all).

The PASCAL system demonstrated noninferiority to the MitraClip system for primary endpoints, with 30-day MAE rates of 4.6% vs. 5.4% and 6-month MR ≤2+ rates of 97.9% vs. 95.7%.

Noninferiority was also met for secondary effectiveness endpoints at 1 year, with MR ≤2+ rates of 95.8% vs. 93.8% and MR ≤1+ rates of 77.1% vs. 71.3%.

Both groups showed sustained improvements in functional classification and quality of life (P < 0.05 for all vs. baseline).

The results affirm the PASCAL system as a beneficial therapy for prohibitive-surgical-risk patients with significant symptomatic DMR. Link to article: https://doi.org/10.1016/j.jcin.2023.10.002