What are the signs and symptoms of heart failure?

The most common symptoms of heart failure are shortness of breath with or without activity and excessive tiredness (fatigue).  Many patients also have swelling (edema) especially in the legs, feet, lungs, and abdomen. Patients often have difficulty performing activities of daily living such as climbing stairs, walking short distances, or working full time. Chest pain and weight gain can also occur.

How is Heart Failure treated? 

Heart failure is a serious medical condition. Heart failure affects more than 5 million people in the United States with almost half a million new cases each year.

Fortunately, doctors have many medications and treatment options available that can help improve heart failure symptoms and reduce the impact heart failure has on a patient’s daily life.  Current treatments include lifestyle modifications (including healthy eating habits, regular exercise, quitting smoking and weight loss). Most patients also take medications such as ACE inhibitors, beta blockers, and diuretics. These drugs help the heart beat stronger and reduce the amount of swelling and extra fluid in the body. 

Despite these medications some patients continue to have a lot of disabling heart failure symptoms. Some patients can benefit from surgical procedures such as cardiac pacemakers and defibrillators, heart surgeries (mitral valve repair or replacement, or coronary artery bypass), LVADs (Left Ventricular Assist Devices), or a heart transplant.

Clinical trials are also currently assessing investigational devices, such as Acorn’s CorCap Cardiac Support Device, as potential therapies for patients with moderate to severe heart failure.  The CorCap is a polyester mesh fabric that is placed around the heart.  It is designed to provide support to the heart, which could reduce the stress that causes the heart to enlarge.  By reducing the stress on the heart, the heart may be able to repair itself and become a smaller, more efficient pump and reduce the impact of common heart failure symptoms on daily life.

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What is the Acorn CorCap™ Cardiac Support Device and how does it work?

The Acorn CorCap™ Cardiac Support Device is an investigational device that is being studied as a treatment for patients with moderate to severe heart failure.  The CorCap™ CSD is a polyester mesh fabric that is placed around the heart.  It is designed to provide support to the heart, which could reduce the stress that causes the heart to enlarge.  By reducing the stress on the heart, the heart may be able to repair itself and become a smaller, more efficient pump and reduce the impact of common heart failure symptoms on daily life.

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What is a clinical research study?

A “Clinical Research Study” or “Clinical Trial” is the scientific term for a test of drugs or medical devices in people. These tests are done to see if the product is safe and effective for people to use. By taking part in a clinical study, you can try a new treatment that may or may not be better than those that already exist. You can also help others better understand how the treatment works in people and contribute to the advancement of science. Because the treatments being studied are new, doctors don’t always know what the side effects will be. Many side effects are temporary and go away when treatment is stopped, others may be permanent. The risks will always be fully explained to you by the researchers before you participate in a study.

The US Food and Drug Administration (FDA) and the hospitals require that you be given a document called an “informed consent” that tells you all about the clinical study: the purpose of the research, how long the study will take, the risks, any potential benefits, and letting you know that you can quit the study at any time. Only after you read and understand the study completely will you be able to participate and potentially receive the treatment.

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What will happen if I want to take part in an Acorn research study?

You will first go over your medical history and medical records with the research center doctors and staff. They will help to determine if you meet the medical requirements (criteria) for this study and if it is an appropriate treatment option for you

• If you meet all of the initial requirements (criteria), you will be given more information about the study including the purpose of the research, the timeline, risks, benefits, and your rights as a patient . You will then be required to sign an Informed Consent document to participate in the clinical study. An Informed Consent document is used to give you the key facts about the clinical research study so that you can decide whether or not you wish to participate. The Informed Consent is not a contract. Your participation in the study is completely voluntary. If you decide to take part in the study, you are free to quit at any time, however, the CorCap™ device is a permanent implant and most likely cannot be removed once it has been implanted. 

• After you sign the Informed Consent you will have more tests to make sure you qualify for the clinical research study and confirm the current state of your heart failure.  These tests include a medical exam, blood tests, a six-minute walk test to evaluate how far you can walk in 6 minutes, a quality of life survey, a heart ultrasound (Echocardiogram), EKG, and a pregnancy test if you are a female and able to become pregnant. Your doctor may also decide that you need a pulmonary function test to evaluate how well your lungs work and/or a left heart catheterization to look for blockages in the arteries in your heart.  These tests may determine that you do not qualify to participate in the study and you will not have the CorCap™ device implanted.

• If you do meet all requirements to participate in the study, you will be scheduled for the surgery and have the CorCap™ implanted. You will continue to receive optimal medical and device therapy under the care of the research center doctors and their staff.

• After your surgery you will be scheduled to return to the research center for several follow up visits. You will have some of the same tests that you had to qualify for the study. You will also be asked questions about any side effects and hospital visits you have had.  You will be followed by telephone calls only after one year. Your participation in the study is expected to last 5 years.

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Will it cost anything to participate in an Acorn research study?

There should not be any additional costs to you if you participate in an Acorn CorCap clinical research study. Items related to routine medical care that you would receive even if you did not participate in the study will be billed to you or your insurance company. Costs directly related to the study that are not covered by insurance will be covered by the study sponsor, Acorn Cardiovascular, Inc.

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Will I be paid to participate in an Acorn research study?

You will not be paid to participate in this study. You will be reimbursed by the study sponsor, Acorn Cardiovascular, Inc. for reasonable study related travel expenses including mileage, parking, taxis, meals and hotels as necessary. You will not be reimbursed for expenses for other family members.

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How do I find out if I am a candidate for an Acorn research study?

To see if you may qualify to participate in the study, go to “Am I a Candidate” and fill out the short survey. If you appear, based on your answers, to meet the initial medical requirements, then you will be asked to provide your contact information so the study staff can contact you for additional information. Thank you!

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