Cooper Heart Institute Selected for International Clinical Trial Comparing Heart Devices

First in New Jersey to Implant Amulet Device

Sajjad A. Sabir, MD

Sajjad A. Sabir, MD

The Cooper Heart Institute recently became one of the first hospitals in the United States and the only one in the Northeast region to participate in a clinical trial comparing the effectiveness of two devices designed to reduce the risk of stroke in patients with atrial fibrillation.

“Atrial fibrillation (AFib) is an irregular heartbeat that can cause blood to pool and form clots in the left atrial appendage (LAA), a small pouch on the left side of the heart,” explained Cooper cardiologist Sajjad A. Sabir, MD, Director of the Cooper Structural Heart Disease Program. “For patients with non-valvular AFib, the LAA is the source of the majority of those stroke-causing blood clots.”

According to the American Heart Association, at least 2.7 million Americans are living with AFib. People with atrial fibrillation are five- to seven-times more likely to have a stroke than the general population.

The clinical trial will compare St. Jude Medical’s AMPLATZER™ Amulet™ cardiac implant with Boston Scientific’s WATCHMAN™ device. Both devices are intended to prevent clots from entering the bloodstream, where they can travel to the brain and cause strokes.

As part of the clinical trial, a multidisciplinary team at the Cooper Heart Institute, led by Janah Aji, MD, FACC, Director of the Cooper Cardiac Catheterization Lab, and George E. Mark, MD, FACC, of The Heart House, implanted two of the Amulet devices in patients the week of April 24, 2017, the first in the state of New Jersey.

The two devices differ in design. The WATCHMAN device, which resembles a tiny umbrella, is inserted through a catheter in the groin area to seal off the LAA. The AMPLATZER Amulet occluder is a plug-like device designed to block the left atrial appendage at its opening, minimizing the opportunity for blood clots to form and travel into the bloodstream.

The study will compare procedure-related complications, all-cause deaths, and major bleeding at 12 months and track strokes occurring in patients following implantation of one of these devices.

In earlier studies, both devices have proven effective in reducing the risk of stroke in patients with AFib.

For decades, most people with atrial fibrillation have been treated with long term blood-thinner therapy. While blood thinners can reduce the risk of stroke, they can also create complications, such as internal bleeding, said Dr. Sabir.


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