Have you developed HEART
FAILURE following a heart attack?

See if the CardiAMP Heart Failure Trial is right for you

Heart failure can be a confusing term. It does not mean that your heart has stopped working – but instead that your heart can’t pump enough blood to meet your body’s needs. This can cause troubling symptoms such as fatigue, shortness of breath, and swelling in the legs and ankles.

Heart failure is quite common, affecting nearly 6 million Americans. For many, their heart failure develops after a heart attack, which can damage and weaken the heart muscle.

If you’ve had a heart attack and now suffer from heart failure, you may be a candidate for the CardiAMP Heart Failure Trial. The study is evaluating CardiAMP Therapy, which uses your own bone marrow cells to potentially stimulate the body’s natural healing response, all through a minimally-invasive, catheter-based procedure.

What is CardiAMP Therapy?

Bone marrow is a unique substance found in the center of some of the larger bones in our bodies, such as the hipbones. Bone marrow is where new blood cells are produced. For many years, doctors have studied how bone marrow cells can help stimulate the body’s natural healing response.

CardiAMP Therapy is designed for people who have had a heart attack, and now suffer from heart failure. It is an investigational therapy that uses your own bone marrow cells to potentially stimulate the body’s natural healing response, all through a minimally-invasive procedure.

The entire CardiAMP Therapy procedure takes about one hour (following a pre-procedural assessment to see if CardiAMP Therapy may be right for you). First, a needle is inserted into the hipbone to collect a small amount of bone marrow. The bone marrow is then put through a special process to prepare the cells for transfer to the heart. Finally, a single small incision is made in the groin and a thin, flexible catheter is advanced to the heart. The catheter enables the bone marrow cells to be injected directly into the damaged regions of your heart. (CardiAMP Therapy Illustration)

Right now, doctors at select treatment centers in the US are conducting a new research study to evaluate the ability of CardiAMP Therapy to improve cardiovascular function and quality of life (The CardiAMP Heart Failure Trial). If you’ve previously suffered a heart attack, and now have heart failure, this study may be right for you.

Frequent Questions
Clinical studies (also called clinical trials) are used to learn about the safety and effectiveness of possible new medications, medical devices, and medical procedures. Although there are many types of clinical trials, all must conform to strict rules set by the U.S. Food and Drug Administration (FDA). These rules help protect the rights and safety of those who volunteer to take part in clinical trials.

2. What is CardiAMP Cell Therapy?

CardiAMP Therapy is an investigational therapy for people who have had a heart attack, and now suffer from heart failure. CardiAMP Therapy uses your own bone marrow cells to potentially stimulate the body’s natural healing response, all through a minimally-invasive, catheter-based procedure.

3. Can I receive CardiAMP Cell Therapy without joining the study?

No, CardiAMP Therapy is currently only available in the US through the CardiAMP Heart Failure Trial.

4. Will I receive CardiAMP Cell Therapy if I qualify for the study?

The study participants who qualify for the study will be randomly placed into one of two groups, a treatment group or a control group. If you are placed into the treatment group, you will receive the cell therapy. If you are placed in the control group, you will have a simulated procedure and the cells will not be administered. Neither the study participant nor the researcher responsible for post-procedure care will know who have received the cell therapy and who had the simulated procedure. Both groups will be closely monitored throughout the study by a team of physicians and continue to be cared for with standard of care medical treatments.

5. If I am randomized to the control group during the study, will I be given the opportunity to receive the cell therapy after the study has been completed?

If you are randomized to the control group and complete the clinical check-ups during the study, you will be given the option to receive the cell therapy after study completion.

6. How many people will participate in the CardiAMP Heart Failure Trial?

About 260 people are expected to participate in the study.

7. How long does the study last?

If you join the study, your participation will last approximately 2 years. Following your procedure, you will return to your study doctor’s office for 5 follow-up visits over the first year, and then one more annual visit. These visits are an important part of the study, as they allow your doctor to closely monitor your individual results and experiences.

8. What if I join the study and decide I do not want to participate anymore?

As with all clinical studies, your participation is completely voluntary and you may choose to leave the study at any time.

9. I am interested in hearing more. What is the next step?

To see if you might qualify for the CardiAMP Heart Failure Trial, and to be referred to a study center in your area, the next step is taking the pre-screening questionnaire. Please click here to get started.

10. I am not yet ready to pre-screen, but I have additional questions. Is there a number I can call?

If you still have questions or would like additional information regarding the CardiAMP Heart Failure Trial, please call (888) 468-9303.

For additional information about the CardiAMP Heart Failure Study, visit: www.ClinicalTrials.gov

To learn more about the study sponsor BioCardia, Inc., please visit www.BioCardia.com

See If You Qualify

To see if you might qualify for the CardiAMP Heart Failure Trial, and to get connected with the study center in your area to learn more, please take the questionnaire below.