Alleviant Device for Heart Failure

Recruiting in Palo Alto (17 mi)

+101 other locations

Overseen byJames Udelson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Alleviant Medical, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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

This trial is for people with heart failure who can still move around (NYHA Class II, III or ambulatory IV) and have a specific type of heart function (LVEF ≥ 40%). They must show high pressure in the left part of their heart during exercise and not have advanced heart failure, pacemakers, or right heart issues.

Inclusion Criteria

I am on a stable heart or blood pressure medication regimen.

I have mild to moderate heart condition but can still move around.

Your heart pressure is too high during exercise testing.

+3 more

Exclusion Criteria

My condition is advanced heart failure.

You have a pacemaker.

There are signs of problems with the right side of your heart.

Participant Groups

The study tests the Alleviant ALV1 System—a device to create a small channel between the left and right sides of the heart—against a sham procedure. Participants won't know which they receive in this controlled comparison to see if it's safe and helps symptoms.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

Subjects randomized to the treatment arm will undergo cardiac imaging, femoral vein access and receive the Alleviant ALV1 System device procedure.

Group II: ControlPlacebo Group1 Intervention

Subjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein.