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Alleviant ALLAY-HF Study

Alleviant ALLAY-HF Study

Recruiting
40 years and older
All
Phase N/A
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  • Simplified (AI rewritten)

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Overview

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

Inclusion Criteria:

  1. Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
  2. NYHA Class II, III or ambulatory IV
  3. Exercise right heart catheterization\*
    1. Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
    2. Exercise PVR \< 1.8 WU
  4. Ongoing stable GDMT

Exclusion Criteria:

  1. Advanced heart failure
  2. Presence of a pacemaker
  3. Evidence of right heart dysfunction

Study details
    Heart Failure

NCT05685303

Alleviant Medical, Inc.

15 August 2026

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