Alleviant ALLAY-HFrEF Study

Not Applicable

• Conditions: Heart Failure

• Registration Number: NCT06812533
• Lead Sponsor: Alleviant Medical, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-03
• Study First Posted: 2025-02-06
• Study Start: 2025-03-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-04
• Last Update Posted: 2025-05-06
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 350

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Composite Primary Endpoint	12-Month	The primary endpoint is a composite of all-cause mortality or cardiac transplantation or permanent left ventricular assist device (LVAD) and heart failure events.

Trial Locations

Locations (6)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Mission Hospital; 🇺🇸 Asheville, North Carolina, United States

Ascension Sacred Heart; 🇺🇸 Pensacola, Florida, United States

Cardiovascular Institute of the South; 🇺🇸 Houma, Louisiana, United States

Hendrick Health; 🇺🇸 Abilene, Texas, United States

Tbilisi Heart and Vascular; 🇬🇪 Tbilisi, Georgia