Alleviant ALLAY-HF Study

Alleviant Medical

Status: Invitation-only

Conditions: Heart Failure

Treatments: Other: Sham-Control; Device: Alleviant ALV1 System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05685303

CIP-0003

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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500 participants in 2 patient groups

Treatment

Experimental group

Description:

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

Treatment:

Device: Alleviant ALV1 System

Control

Sham Comparator group

Description:

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

Treatment:

Other: Sham-Control