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

The purpose of this study is to evaluate the safety and efficacy of the Alleviant ALV1 System in patients with chronic heart failure (HF) and preserved ejection fraction (HFpEF) or mildly reduced ejection fraction (HFmrEF), who remain symptomatic despite appropriate guideline directed medical therapy (GDMT).

Clinical Study Identifier: s22-01225

ClinicalTrials.gov Identifier: NCT05685303

Principal Investigator: Tajinderpal Saraon.

Other Investigators: Michael Divita, Alex Reyentovich, Cezar S Staniloae, Randal Ian Goldberg, Mathew R. Williams, Bernard Shown Kadosh.

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