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Ascension St. Vincent's Riverside chosen for Watchman FLX clinical trial

The Watchman FLX device is used as part of a minimally invasive procedure for patients with atrial fibrillation.

A procedure for afib could replace a lifetime of meds for some patients.

Ascension St. Vincent’s Riverside has been chosen to participate in a new clinical trial for the Watchman FLX, a minimally invasive procedure for patients with atrial fibrillation.

Dr. Saumil Oza, chief of cardiology at St. Vincent’s Medical Center in Jacksonville, says the risk of stroke increases 500% for patients with afib. In the past, those patients have been put on anticoagulants, or blood thinners, to decrease the risk of developing blood clots that can get loose and cut off the blood supply to the brain, causing a stroke. For many patients, however, blood thinners are a problem.

“Some patients have frequent falls and are at high risk of banging their head and causing a brain bleed,” Oza says. “Others have an allergic reaction or suffer from side effects.”

For the past 10 years, Watchman has been studied for patients with afib who cannot tolerate blood thinners, but the new Champion-AF clinical trial opens this option to patients who should not take blood thinners because of high-risk jobs or hobbies, or who just do not like taking them.

Ascension St. Vincent’s Riverside was chosen, in part, because it is one of the top three enrollers worldwide for the current Option trial, which studies options for treatment (blood thinner or the Watchman procedure) after an atrial fibrillation ablation.

In all current trials, Oza says the Watchman has proven as effective as blood thinners in reducing the risk of blood clots.

The hospital began enrolling patients for the Champion trial in January, a process that can take years. Once patients are enrolled, they will be studied for several years, after which the FDA would have to sign off on its use.

“This is going to give that choice to anybody that has atrial fibrillation,” Oza says. “And that has the potential to reach hundreds of thousands, if not millions, of people nationwide.”   


Read more in Florida Trend's February issue.
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