Interatrial Shunt Treatment for Heart Failure: The Randomized RELIEVE-HF Trial.

ABSTRACT:

Background

An interatrial shunt may provide an autoregulatory mechanism to decrease left atrial pressure and improve heart failure (HF) symptoms and prognosis.

Methods

Patients with symptomatic HF with any left ventricular ejection fraction (LVEF) were randomized 1:1 to transcatheter shunt implantation versus a placebo procedure, stratified by reduced (≤40%) versus preserved (>40%) LVEF. The primary safety outcome was a composite of device-related or procedure-related major adverse cardiovascular or neurological events at 30 days compared with a prespecified performance goal of 11%. The primary effectiveness outcome was the hierarchical composite ranking of all-cause death, cardiac transplantation or left ventricular assist device implantation, HF hospitalization, outpatient

SUBMITTER: Stone GW 

PROVIDER: S-EPMC11627316 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature