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Alleviant ALLAY-HFrEF Study

NCT06812533 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-04-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Alleviant ALV1 System

Creation of interatrial shunt

OTHER

Sham-Control

Cardiac imaging

Sponsors & Collaborators

  • Alleviant Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Gregg Stone · Icahn School of Medicine at Mount Sinai

  • James Udelson · Tufts Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Georgia
  • Greece
  • Israel
  • New Zealand
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06812533 on ClinicalTrials.gov