NCT06812533 · Alleviant Medical, Inc.
Alleviant ALLAY-HFrEF Study
What this study is about
forward-looking, conducted at multiple hospitals, randomly assigned, sham-controlled, double blind (patient and observer), study designed to evaluate the safety and effectiveness of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFrEF.
View original scientific description
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.
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 all-cause mortality or cardiac transplantation or permanent left ventricular assist device (LVAD) and heart failure events.
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
- 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
Where
- Los Angeles, California
- Sacramento, California
- San Diego, California
- San Francisco, California
- Delray Beach, Florida
- Pensacola, Florida
- Tampa, Florida
- Decatur, Georgia
- Naperville, Illinois
- Houma, Louisiana
- New Orleans, Louisiana
- Boston, Massachusetts
And 22 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