Are You Living with Heart Failure?

The RELIEVE-HF randomized clinical trial is currently evaluating a new investigational implantable medical device for patients diagnosed with heart failure.

What is Heart Failure?

Heart failure means that the heart is not pumping enough blood to meet the needs of the body. When this occurs, there is an increase in pressure in the heart and lungs, plus fluid build-up in the lungs. The fluid causes congestion and makes it hard to breathe during activities or even when at rest.

In addition to shortness of breath, other symptoms associated with heart failure include general fatigue, tiredness, and rapid weight gain. Many people with heart failure also have swollen legs and feet.

Treatments for heart failure typically focus on providing relief from these symptoms, improving patients quality of life, and helping to keep patients out of the hospital. Treatments may include medication, lifestyle changes and other interventions including medical devices.

Common Heart Failure symptoms include:

Shortness of breath

During exercise or at rest

Fatigue

Lower Activity Levels

The RELIEVE-HF Randomized Clinical Study

In 2018, V-Wave received regulatory approval to conduct a large clinical trial called RELIEVE-HF. This study is assessing the effects of the V-Wave Ventura® Interatrial Shunt System on patients with heart failure, specifically the potential for reducing the need for hospitalization and improving symptoms, exercise ability, and quality of life.

What is the study design?
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The RELIEVE-HF Study Design

The RELIEVE-HF clinical research study will enroll more than 500 patients, including 400 or more in a randomized cohort, at more than 120 sites around the world. Patients will be assigned at random to either (a) treatment group that receives the implantable shunt or (b) control group that receives conventional medical care. Neither the patient nor their physician will know the assignment until the completion of the randomized phase of the study. For patients randomized to medical care, they will have an option for the V-Wave shunt implant available at the end of the randomized phase of the trial if they remain eligible for study.
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What is an Interatrial Shunt?

An interatrial shunt is a medical device designed to lower pressure on the left side of the heart by allowing a small amount of blood to pass from the left to the right atrium. This reduces pressure on the left side when it is needed, such as during exertion or with excessive fluid retention. The goal of the shunt is to help patients feel better and stay out of the hospital.

The V-Wave Ventura Interatrial Shunt System

CAUTION: Investigational Device, limited by Federal U.S. law to investigational use. To be used by Qualified Investigators only.

The V-Wave Ventura Interatrial Shunt is a small, hourglass-shaped device with a small opening in the middle that allows blood flow from the left atrium to the right atrium. The device is made of specialized materials approved for and commonly used in other implantable medical devices. It is implanted by a cardiologist during a catheterization procedure in a specialized hospital room.

In 2019, the U.S. Food and Drug Administration (FDA) designated the V-Wave Ventura Interatrial Shunt system as a Breakthrough Device.

Can You Be Included in the Trial?

If you are interested in being a participant in the RELIEVE-HF Clinical Study, the study doctor will discuss all study procedures and requirements of the study, as well as the potential benefits and risks.

You may be eligible for the study if you:

  • Have been told you have heart failure (HF) that causes symptoms such as shortness of breath, fatigue, or difficulty performing daily activities (defined as New York Heart Class II, III, or ambulatory Class IV HF¹); and
  • Have had a hospital admission for heart failure within the past twelve (12) months and/or an elevation in a certain blood test for HF called BNP or NT pro-BNP.

Discuss your medical history with your physician to see if the RELIEVE-HF trial is right for you.

¹ Candidates in Germany and Switzerland must have either New York Heart Class III or ambulatory Class IV HF.

Hear More from the Experts

Click on this video to hear directly from two of RELIEVE-HF’s principal investigators on how the study was designed, what patient benefits they’re looking to see, and reasons why candidate patients and their families may want to consider participating in a clinical trial.

Ready to Learn More?

Know Your Medical History?

Take a brief, anonymous quiz to see if you might be eligible for the RELIEVE-HF clinical study
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Looking for Trial Sites?

Review the current study site directory to locate a site near you.
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