Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients with Chronic Heart Failure (ALLAY-HF)

Brief description of study

ALLAY-HF is a prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF. Patients will be randomized in a 1:1 ratio to undergo the investigational device procedure or a sham-control procedure. The primary analysis will be performed after all study subjects have the opportunity to complete 12 months of follow-up. Regular follow-up visits are planned to occur through 5 years after the index procedure for all study subjects. Sham-control subjects will be offered an opportunity to cross-over after the 24-month follow-up and undergo the investigational device procedure if they meet study eligibility criteria at that time.


Clinical Study Identifier: s22-01225
ClinicalTrials.gov Identifier: NCT05685303
Principal Investigator: Tajinderpal Saraon.
Other Investigators: Michael Divita, Samuel Bernard, Alex Reyentovich, Cezar S Staniloae, Randal Ian Goldberg, Amanda Bitetti, Rafael Harari, Mathew R. Williams, Erin E Flattery, Bernard Shown Kadosh, Binita Shah.


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