Low Risk TAVR Clinical Trial

New Study Investigates Minimally Invasive Procedure for Failing Heart Valve

Physicians at MedStar Heart & Vascular Institute at MedStar Union Memorial Hospital are now investigating a minimally invasive procedure for patients who have severe aortic stenosis, need a replacement heart valve, and are healthy enough to undergo surgery.

Aortic stenosis is a common heart problem caused by a narrowing of the heart’s aortic valve due to excessive calcium build-up. When the valve narrows, it does not open or close properly, making the heart work harder to pump blood throughout the body. Eventually, this causes the heart to weaken and function poorly, which may lead to heart failure and increased risk for sudden cardiac death. The study will explore the safety and effectiveness of a Transcatheter Aortic Valve Replacement – commonly known as “TAVR” – as an alternative to open-heart surgery.

Bringing a New Investigational TAVR Device to Low-Risk Patients

 The study will explore the use of a device called the CoreValve® and Evolut® R System which replaces the failing heart valve. The device is unique in that it is the only repositionable, self-expanding TAVR system that is currently commercially available in the United States.

MedStar Union Memorial Hospital was selected to conduct the study because it is a regional leader in performing the TAVR procedure. MedStar Union Memorial Hospital cardiologists have completed more than 300 TAVR procedures, with stellar outcomes since it was first introduced in 2012. The study will be led by Dr. John Wang, Chief of the Cardiac Catheterization Laboratory at MedStar Union Memorial Hospital and Scientific Director for Baltimore Cardiovascular Research and Dr. Michael Fiocco, Chief of Cardiac Surgery at MedStar Union Memorial Hospital.

The study will accept up to 1,200 patients worldwide and will follow-up with those patients for up to 10 years.

The study is sponsored by Medtronic and supported by the MedStar Health Research Institute.

About Aortic Stenosis –A Serious Heart Condition

An estimated 2.5 million people over the age of 75 suffer from aortic stenosis or failing heart value, which is caused by calcium build-up in the aortic valve. Symptoms can vary and change over time, but can include: fatigue, dizziness, chest pain, heart murmur, shortness of breath during activity, heart palpitations and fainting. If left untreated, a failing heart valve can lead to serious heart problems, including heart failure and even death.

About MedStar Health Research Institute

The MedStar Health Research Institute is the research arm of MedStar Health, the largest healthcare provider in Maryland and the Washington, D.C., region. MedStar Health Research Institute provides scientific, administrative and regulatory support for research programs throughout the MedStar Health system. MedStar Health Research Institute’s expertise includes translational research into disease prevention, diagnosis and treatment. These programs complement the key clinical services and teaching programs in the 10 MedStar hospitals and other MedStar entities. Visit us at www.MedstarResearch.org