ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System
NCT05686317
Original registry description
This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.
The objectives of this trial are to assess the safety, performance, and effectiveness of the Edwards APTURE transcatheter shunt system when used for the treatment of patients with heart failure with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction (LVEF \>40%) who remain symptomatic despite guideline-directed medical therapy (GDMT)