Alleviant ALLAY-HF Study

Not Applicable

• Conditions: Heart Failure

• Registration Number: NCT05685303
• Lead Sponsor: Alleviant Medical, Inc.

Brief Summary

Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-14
• Study First Submitted QC: 2023-01-05
• Study Start: 2023-01-10
• Study First Posted: 2023-01-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24
• Primary Completion: 2026-04-01
• Study Completion: 2032-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%

2. NYHA Class II, III or ambulatory IV

3. Exercise right heart catheterization*

   1. Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
   2. Exercise PVR < 1.8 WU

4. Ongoing stable GDMT

Exclusion Criteria

1. Advanced heart failure
2. Presence of a pacemaker
3. 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 mortality, heart failure events and quality of life based on Kansas City Cardiomyopathy Questionnaire (KCCQ) calculated at 12 months. KCCQ responses are provided along a rating scale from 0-100 with a higher score indicating better health.

Trial Locations

Locations (87)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Arizona Cardiovascular Research Center; 🇺🇸 Phoenix, Arizona, United States

Pima Heart and Vascular; 🇺🇸 Tucson, Arizona, United States

Memorial Care Long Beach Medical Center; 🇺🇸 Long Beach, California, United States

Scripps Clinical Research Services; 🇺🇸 San Diego, California, United States

San Francisco VA; 🇺🇸 San Francisco, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Santa Barbara Cottage Hospital; 🇺🇸 Santa Barbara, California, United States

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

The Cardiac and Vascular Institute (TCAVI); 🇺🇸 Gainesville, Florida, United States

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