Alleviant ALLAY-HFrEF Study

Conditions

• Heart Failure

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Alleviant ALV1 System — DEVICE
  Creation of interatrial shunt
• Sham-Control — OTHER
  Cardiac imaging

Study Details

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.

Key Dates

Start date

Mar 10, 2025

Status verified

Jun 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

350 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Treatment
  Subjects randomized to the treatment arm will undergo cardiac imaging, femoral vein access and receive the Alleviant ALV1 System device procedure.
• Sham Comparator: Control
  Subjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein.

Primary Outcome Measure

Composite Primary Endpoint [ Time Frame: 12-Month ]

Locations (35)

Find similar trials in Los Angeles, CA

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