A Phase 2b/3, Randomized, Double-Blinded, Placebo Controlled Study ChecKing the Efficacy and Safety of ATAciguat to Slow the Progression of VaLvular DYsfunction in Participants with Moderate Calcific Aortic Valve STenosis (KATALYST-AV)

Condition studied

Moderate Calcific Aortic Valve Stenosis (CAVS)

Investigational medicinal product(s)

Eligibility

Primary endpoint

1. (Part B) Percent change in AVA as measured by echocardiogram from baseline to Week 48, 2. (Part B) Change in peak VO2 as assessed by CPET from baseline to Week 48

Endpoint detail

1. (Part B) Change in AVC score as assessed by non-contrast CT from baseline to Week 48., 2. (Part B) Time to decision to proceed with TAVR/SAVR or all-cause death; Percentage of participants with AS progression to AVA <1.0cm2 at Week 48