WATCHMAN FLX™ in Clinical Trial at MedStar Heart & Vascular Institute

June 12, 2018

Study of Stroke Prevention Device Which May Give Physicians More Flexibility in Optimal Cardiac Positioning

 

Washington, D.C., June 12, 2018 – MedStar Heart & Vascular Institute physicians participating in a clinical trial have become the first in the Mid-Atlantic region to implant the next generation of a potentially life-changing device proven to reduce the risk of stroke in certain patients with atrial fibrillation (AFib).

Watchman Notice

The next-generation device, called the WATCHMAN FLX™, is being studied for its ability to provide doctors with greater flexibility and safety while positioning the device in the left atrial appendage, a sub-chamber of the heart where blood can pool and form clots. Those clots may then escape into the circulatory system and block blood flow to brain tissue.

“Our participation in this clinical trial is an example of how the comprehensive AFib program at MedStar Heart & Vascular Institute at MedStar Washington Hospital Center is providing patients with access to cutting-edge devices and treatments before they are widely available,” said Manish Shah, MD, director of the Clinical Cardiac Electrophysiology Fellowship Training Program at the Hospital Center and principal investigator for the new trial.

MedStar Heart &Vascular Institute is one of approximately 40 sites in the U.S. selected for WATCHMAN FLX implantation, and Dr. Shah is currently the leading implanter of devices nationwide.

AFib is the most common cardiac arrhythmia in adults, affecting more than five million Americans, and is expected to become even more common as the population ages. AFib causes about 20 percent of all strokes, and strokes from AFib are particularly severe and twice as likely to cause death or incapacitation compared to strokes from other causes.

Blood thinners are commonly prescribed to patients with AFib to reduce their risk of stroke, but patients and their physicians often have reservations about these types of drugs because of bleeding risks, especially in those patients with an increased risk of falls, along with the potential for medication interactions. As a result, up to 45 percent of patients with AFib may go untreated and unprotected from stroke.

WATCHMAN FLX is designed to prevent the movement of blood clots formed within the left atrial appendage into the bloodstream, thereby protecting patients from AFib-related strokes.

“Atrial fibrillation and its consequences are a growing epidemic, especially as our population ages,” said Stuart F. Seides, MD, physician executive director, MedStar Heart & Vascular Institute. “The refinement of a tool that may prevent strokes more securely in more patients is welcome.”

The first version of WATCHMAN™ became available internationally in 2009, and since then various generations of the device have been implanted more than 50,000 times.

Patients or physicians interested in learning more about this study and possible participation, please contact clinical study coordinator, Roshila Mohammed, at 202-877-0805.

 


About MedStar Heart & Vascular Institute
MedStar Heart & Vascular Institute is a national leader in the research, diagnosis and treatment of cardiovascular disease. A network of 10 hospitals and 150 cardiovascular physicians throughout Maryland, Northern Virginia and the Greater Washington, D.C., region, MedStar Heart also offers a clinical and research alliance with Cleveland Clinic Heart & Vascular Institute, the nation’s #1 heart program. Together, they have forged a relationship of shared expertise to enhance quality, improve safety and increase access to advanced services. MedStar Heart & Vascular Institute was founded at MedStar Washington Hospital Center, home to the Nancy and Harold Zirkin Heart & Vascular Hospital. Opened in July 2016, the hospital ushered in a new era of coordinated, centralized specialty care for patients with even the most complex heart and vascular diagnoses.

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