Alleviant ALLAY-HF Study

Enrolling by invitation · Not applicable · Has a placebo group

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT05685303

Run by

Alleviant Medical, Inc.

People needed

700

Starts

2023-01-10

Expected to finish

2032-12-01

Last updated by the study team

2026-05-04

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
• NYHA Class II, III or ambulatory IV
• Exercise right heart catheterization*
• Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
• Exercise PVR < 1.8 WU
• Ongoing stable GDMT

You may not qualify if…

• Advanced heart failure
• Presence of a pacemaker
• Evidence of right heart dysfunction

Where it is running

• 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
• UC Davis Medical Center — Sacramento, 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
• HCA Florida Memorial Hospital — Jacksonville, Florida, United States
• NCH Research Institute — Naples, Florida, United States
• Advent Health Orlando — Orlando, Florida, United States
• Ascension Sacred Heart — Pensacola, Florida, United States
• Atlanta VA Health Care System — Decatur, Georgia, United States
• Advocate Illinois Masonic Medical Center — Chicago, Illinois, United States
• Midwest Cardiovascular Institute — Naperville, Illinois, United States
• Prairie Education and Research Cooperative — Springfield, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• St. Elizabeth Healthcare — Edgewood, Kentucky, United States
• Cardiovascular Institute of the South — Houma, Louisiana, United States
• University Medical Center New Orleans — New Orleans, Louisiana, United States
• Johns Hopkins Medical Institution — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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