Alleviant ALLAY-HFrEF Study

Purpose

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.

Condition

  • Heart Failure

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment 		Subjects randomized to the treatment arm will undergo cardiac imaging, femoral vein access and receive the Alleviant ALV1 System device procedure.
  • Device: Alleviant ALV1 System
    Creation of interatrial shunt
Sham Comparator
Control 		Subjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein.
  • Other: Sham-Control
    Cardiac imaging

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118

More Details

Status
Recruiting
Sponsor
Alleviant Medical, Inc.

Study Contact

Stacia Kraus
612-387-4552
stacia.kraus@alleviantmedical.com