What is an investigational medical device?

An investigational medical device is a device that is intended to be used for medical purposes, but does not yet have approval from the regulatory authorities for its clinical indication. The use of the device is the subject of a clinical trial designed to evaluate the safety and/or effectiveness of the device.

What is the purpose of a clinical study?

Clinical studies are research studies that are designed to establish the safety, performance and effectiveness of investigational medical products and procedures. Read more about the RESPONDER-HF study at www.clinicaltrials.gov.

What is the Corvia® Atrial Shunt?

The Corvia Atrial Shunt is a cardiac implant designed to reduce the pressure in the left side of the heart and lungs. The implant allows blood to flow from the left to the right atrium (the upper chambers of the heart), reducing the pressure in the left atrium, the primary cause of the symptoms of heart failure.

How is the Corvia Atrial Shunt placed?

During a catheter-based procedure, an interventional cardiologist or electrophysiologist inserts a catheter (small tube) in a vein in your groin to access the heart. This catheter is used to create a very small passage in the heart wall between the right and left atria. The doctor places the atrial shunt in the newly created passage to allow blood to flow from the left to the right atrium, decreasing pressure in the left side of the heart and lungs and thereby reducing your heart failure symptoms.

Who can participate?

If you are 40 years or older, have heart failure with preserved ejection fraction (HFpEF), suffer from heart failure symptoms despite medication, and meet study criteria, you may be eligible to participate.

Why should I participate?

Clinical studies help advance medical care. They help us learn about new treatments and provide the evidence necessary to get the therapies approved for broader use. By participating in the RESPONDER-HF study, you have a chance to play a more active role in your health, gain access to a therapy not yet available to the wider public, and help others by contributing to the advancement of science.

What are the benefits and risks associated with study participation?

As is true with any study for a new therapy, there are potential benefits and risks in participating in the RESPONDER-HF study. While a high-level list of potential benefits and risks are provided, the specific risks and benefits associated with RESPONDER-HF will be explained in more detail to you by a member of the clinical team. These benefits and risks will also be described in the informed consent form, a document you will be asked to review before agreeing to participate in the study. Before making a decision about study participation, carefully evaluate the benefits and risks and discuss any concerns with your doctor.

What company is sponsoring the study?

The clinical study is being sponsored by Corvia Medical, Inc., a US medical device company revolutionizing the treatment of heart failure through novel transcatheter cardiovascular devices. For more information on the company, visit www.corviamedical.com.

Am I a candidate?