Heart Center News

A study underway at the Massachusetts General Hospital’s Cardiac Arrhythmia Service is evaluating whether a tiny medical device will offer patients with atrial fibrillation an alternative treatment to blood-thinning medications – medications like Coumadin or Warfarin that prevent blood clots from forming in the heart.

Watchman could offer alternative to medications

27/Jun/2007

A study underway at the Massachusetts General Hospital’s Cardiac Arrhythmia Service is evaluating whether a tiny medical device will offer patients with atrial fibrillation an alternative treatment to blood-thinning medications – medications like Coumadin or Warfarin that prevent blood clots from forming in the heart.

While these medications decrease the likelihood of a stroke by preventing blood clots, they often have dangerous and unpleasant side effects such as bleeding or bruising. Patients taking blood thinners require frequent visits to the doctors for blood tests, sometimes as often as once a week, because the drugs can be affected by other factors such as diet or other medications.
About the StudyThe study, known as PROTECT-AF, may determine whether this experimental device called the Watchman will prevent dangerous clots from entering the bloodstream. The research team will implant the Watchman in study participants with atrial fibrillation. Two out of every three participants will receive the device, which acts like a filtering umbrella, covering the left atrial appendage to prevent clots from moving into the bloodstream.

“Experience with the Watchman device, not only at MGH but world-wide, has been quite positive,” says Vivek Reddy, MD, who is the trial’s primary investigator at the MGH. “In our experience, this is a safe device to implant, and we believe it will be an excellent alternative to Coumadin. It is certainly an option that I consider for all of my patients with atrial fibrillation.”

Researchers are currently enrolling patients. Of the study participants who have already received the Watchman device, above 95 percent have been able to stop taking blood-thinning medications, and in the feasibility study, there have been no reports of stroke during four years of follow-up. More than 500 patients worldwide are currently enrolled in Protect AF. The Watchman, made by Atritech, is currently approved in Europe and is awaiting FDA approval. MGH is one of several clinical trial sites throughout the country.
About Atrial FibrillationAtrial fibrillation is a heart condition that affects more than 2.2 million people. As the most common form of irregular heartbeat, it causes the upper chambers of the heart to beat too fast. This irregularity can cause blood to pool and form clots in an area of the heart called the left atrial appendage. Everyone has a left atrial appendage. The common blood thinning medicines – like Coumadin or Warfarin – require that patients make frequent visits to their doctors for blood tests, sometimes as often as once a week, because the drugs can be affected by other factors such as diet or other medications. They also often have dangerous and unpleasant side effects such as bleeding or bruising.

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