Alleviant ALLAY-HFrEF Study

Alleviant Medical

Status: Invitation-only

Conditions: Heart Failure

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06812533

CIP-0006

Details and patient eligibility

About

Prospective, multicenter, randomized, sham-controlled, double blind (patient and observer), study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFrEF.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• LVEF ≤ 40%
• NYHA class II, III or ambulatory IV HF
• Receiving optimal, maximally tolerated, stable GDMT

Exclusion criteria

• Advanced heart failure
• Life-expectancy < 12 months
• Evidence of right heart dysfunction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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350 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