By InvitationNot Applicable

Alleviant ALLAY-HF Study

United States700 participantsStarted 2023-01-10

Plain-language 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.

Who can participate

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. Advanced heart failure
✕. Presence of a pacemaker
✕. Evidence of right heart dysfunction

What they're measuring

Composite Primary Endpoint

Timeframe: 12-month

Trial details

NCT IDNCT05685303

SponsorAlleviant Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-01

View on ClinicalTrials.gov More Heart Failure trials