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Enrolling By Invitation NCT05685303

Alleviant ALLAY-HF Study

Conditions: Heart Failure

Sex: All

Ages: 40 Years – N/A

Phase: NA

Enrollment: 500

Sponsor: Alleviant Medical, Inc.

Location: Georgia

Summary

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.

Eligibility Criteria

Inclusion Criteria:Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%NYHA Class II, III or ambulatory IVExercise right heart catheterization*Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)Exercise PVR < 1.8 WUOngoing stable GDMTExclusion Criteria:Advanced heart failurePresence of a pacemakerEvidence of right heart dysfunction

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05685303). StuddyBuddy aggregates publicly available trial information.