Spotlight on Clinical Research

February is American Heart Month

Surgery and interventions to correct cardiac conditions have come a long way in recent decades. As procedures and their outcomes continue to improve, doctors continue to push the frontiers of medicine to make them even better.

This month is an ideal time to learn about some of Yale’s innovative clinical research studies that are designed to bring exciting improvements to cardiac care. Below are four examples of state-of-the-art therapies that have the potential to change the treatment of heart disease.

Protection Following Minimally Invasive Aortic Valve Replacement

After undergoing a cardiac procedure, patients often have mini blockages, or microemboli, in the brain. Sometimes they don’t feel quite right afterwards, but often there are no symptoms of these silent mini strokes. Yet they occur after most cardiac procedures and may increase the likelihood of dementia over time.

Doctors at Yale have designed an international multicenter research study to understand and measure the formation of microemboli following transcatheter aortic valve replacement (TAVR). About 90 percent of patients have microemboli after undergoing this new and lifesaving procedure. In this novel study, patients undergo a type of MRI scan that measures the restriction of blood flow in the brain. The study also includes neurocognitive testing to measure language, memory, and other brain functions.

Patients undergoing the TAVR procedure may be eligible for this study, even if they are already enrolled in another clinical trial. This study is the first step toward understanding the frequency of and amount in which these microemboli occur following cardiac procedures. Yale doctors are already working on the next step, which will test a protective device that may prevent these mini blockages from occurring.

Healing Leg Ulcers Caused by Peripheral Vascular Disease

Patients with severe peripheral vascular disease often suffer from ulcers on their lower legs due to lack of oxygen in the bloodstream. This clinical trial is testing a completely new and innovative approach to treating these ulcers, which can spread infection to other parts of the body.

Once patients undergo angioplasty, a procedure to open up the vessels in the leg, a patch is applied to the ulcer. The patch helps speed healing by delivering oxygen to the lesion.

Other potential applications for the patch include treatment of severe wounds. This study, for ulcers associated with peripheral vascular disease, was designed by Yale doctors. Yale is the only institution in the country that is testing the patch for this condition.

Mitral Clip for Heart Failure

Patients with heart failure due to severe mitral regurgitation, in which the heart valve separating the upper and lower chambers on the left side of the heart does not close properly, may be eligible for a clinical trial to test a new treatment.

In the COAPT trial, a minimally invasive procedure is used to place a mitral clip to reduce the amount of mitral regurgitation and slow down the progression of heart failure. The mitral clip is the first minimally invasive mitral device to be developed. Yale is the only institution in Connecticut to offer the novel approach available through this research study.

Biodegradable Scaffold to Open Blocked Heart Vessels

Metallic stents are normally used to treat blocked coronary arteries. This clinical trial involves a biodegradable scaffold, similar to a small mesh tube, that opens vessels and gradually dissolves over a period of about three years.

Metallic stents are implanted for life. If the vessel renarrows, a new stent must be implanted on top of the old one and patients with severe disease may have coronary vessels that are paved with metallic stents. “What’s revolutionary here is you’re essentially allowing the vessel to heal and go back to its normal biology and restore normal function,” said Yale cardiologist Dr. Alexandra Lansky.

Already approved for use in Europe and parts of Latin America and Asia, the Absorb vascular scaffold is currently being tested in a multisite clinical trial around the country as the last step before submission for FDA approval. Yale is one of two sites in Connecticut conducting this cutting edge trial.

To find out if you are eligible for these research studies or to learn more about cardiac clinical trials at Yale, contact Dawn Shaddinger, RN, Clinical Research Manager at 203-737-3570 or dawn.shaddinger@yale.edu.