NCT05685303 · Alleviant Medical, Inc.
Alleviant ALLAY-HF Study
What this study is about
forward-looking, conducted at multiple hospitals, randomly assigned, sham-controlled, double blinded, adaptive study designed to evaluate the safety and effectiveness of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.
View original scientific description
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.
Interventions
DEVICE
Alleviant ALV1 System
Creation of interatrial shunt
OTHER
Sham-Control
Cardiac imaging
Primary outcome measures
Composite Primary Endpoint
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Advanced heart failure
- Presence of a pacemaker
- Evidence of right heart dysfunction
Where
- Phoenix, Arizona
- Scottsdale, Arizona
- Tucson, Arizona
- Long Beach, California
- Sacramento, California
- San Diego, California
- San Francisco, California
- Santa Barbara, California
- Hartford, Connecticut
- Gainesville, Florida
- Jacksonville, Florida
- Naples, Florida
And 41 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 14, 2026 · Source of record for eligibility and locations