Alleviant ALLAY-HF Study
Sponsored by Alleviant Medical, Inc.
About this study
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.
Where this study is enrolling (3)
- Call 520-838-3540
Pima Heart and Vascular
Tucson, Arizona
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- Call 404-321-6111
Atlanta VA Health Care System
Decatur, Georgia
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- I'm interested
Midwest Cardiovascular Institute
Naperville, Illinois
Who can participate
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
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.