Alleviant ALLAY-HF Study

NCT05685303 · tracked via the Priya Life Science Belgium tracker

Sponsor

Alleviant Medical, Inc

Phase

Not applicable

Started

2023-01-10

Last updated

2026-08-14

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

Alleviant ALV1 SystemSham-Control

Alleviant ALV1 System: Creation of interatrial shunt

Sham-Control: Cardiac imaging

Study 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.

Eligibility

Sex

ALL

Min age

40 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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 sites (93)

Facility	City	Region	Status
Arizona Cardiovascular Research Center	Phoenix	Arizona	Active Not Recruiting
HonorHealth	Scottsdale	Arizona	Terminated
Pima Heart and Vascular	Tucson	Arizona	Recruiting
Memorial Care Long Beach Medical Center	Long Beach	California	Recruiting
UC Davis Medical Center	Sacramento	California	Recruiting
Scripps Clinical Research Services	San Diego	California	Recruiting
University of California San Francisco	San Francisco	California	Recruiting
Santa Barbara Cottage Hospital	Santa Barbara	California	Recruiting
Hartford Hospital	Hartford	Connecticut	Terminated
The Cardiac and Vascular Institute (TCAVI)	Gainesville	Florida	Recruiting
HCA Florida Memorial Hospital	Jacksonville	Florida	Recruiting
NCH Research Institute	Naples	Florida	Recruiting
Advent Health Orlando	Orlando	Florida	Recruiting
Ascension Sacred Heart	Pensacola	Florida	Recruiting
Atlanta VA Health Care System	Decatur	Georgia	Recruiting
Advocate Illinois Masonic Medical Center	Chicago	Illinois	Terminated
Midwest Cardiovascular Institute	Naperville	Illinois	Recruiting
Prairie Education and Research Cooperative	Springfield	Illinois	Active Not Recruiting
Indiana University	Indianapolis	Indiana	Recruiting
St. Elizabeth Healthcare	Edgewood	Kentucky	Recruiting
Cardiovascular Institute of the South	Houma	Louisiana	Recruiting
University Medical Center New Orleans	New Orleans	Louisiana	Recruiting
Johns Hopkins Medical Institution	Baltimore	Maryland	Recruiting
Brigham and Women's Hospital	Boston	Massachusetts	Recruiting
Boston Medical Center	Boston	Massachusetts	Recruiting
Steward St. Elizabeth's Medical Center	Brighton	Massachusetts	Terminated
VA Ann Arbor	Ann Arbor	Michigan	Recruiting
Ascension St. John Hospital	Detroit	Michigan	Terminated
Minneapolis Heart Institute Foundation	Minneapolis	Minnesota	Recruiting
Washington University - St Louis	St Louis	Missouri	Recruiting
UMC of Southern Nevada	Las Vegas	Nevada	Recruiting
VA NY Harbor Healthcare System	New York	New York	Terminated
New York University	New York	New York	Recruiting
Lenox Hill Hospital	New York	New York	Active Not Recruiting
St. Francis Hospital	Roslyn	New York	Terminated
Stony Brook Medicine	Stony Brook	New York	Recruiting
Mission Hospital	Asheville	North Carolina	Recruiting
Duke University Hospital	Durham	North Carolina	Recruiting
NC Heart and Vascular Research	Raleigh	North Carolina	Recruiting
Cleveland Clinic	Cleveland	Ohio	Recruiting

+ 53 more sites — see the full list on the official registry below.

More Alleviant Medical, Inc. trials in Belgium

Alleviant ALLAY-HFrEF Study Recruiting

Other trials for the same condition

Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure Recruiting

Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF) Active, not recruiting

BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software Recruiting

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure Recruiting

The Assessment of Partial Guideline-Directed Medical Therapy Down Titration in Heart Failure in Remission. Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05685303 on ClinicalTrials.gov ↗ ← All trials in Belgium