ASAP-TOO clinical trial with Boston Scientific opens WATCHMANTM LAAC device to new patients
Nearly two years after being the first commercial site in New England to implant the WATCHMANTM Left Atrial Appendage Closure (LAAC) device, Catholic Medical Center (CMC) has performed the procedure on previously ineligible patients.
CMC is the first hospital in the world to enroll patients in Boston Scientific’s ASAP-TOO clinical trial, which is testing the efficacy of the WATCHMANTM device in patients who cannot tolerate warfarin or any other kind of blood thinner. The WATCHMANTMwas developed as an alternative for patients with non-valvular atrial fibrillation (A-Fib) who were taking long-term blood thinners to help reduce the risk of stroke. Until now, however, patients still needed to follow a blood thinning regimen for a period of time following surgery.
“I had major fear of stroke after being diagnosed with A-Fib,” said Edie Hinds, the first woman enrolled in the trial. She discovered shortly after being prescribed blood thinners that she couldn’t take them. That’s when she was told about the ASAP-TOO trial. “I knew (taking part) was the only intelligent choice I could make.” She was the first woman accepted into the trial in February and went home the day after surgery.
“Patients with A-Fib have a higher risk of stroke but treatment has been limited for those who couldn’t take blood thinners,” said cardiologist Connor Haugh, MD, FACC of CMC’s New England Heart & Vascular Institute. Dr. Haugh implanted the first device in the trial February 15th. “This is a truly exciting option for both patients and us as their caregivers.”
“Boston Scientific is fortunate to have such a strong partner who is focused on procedural efficiencies and clinical outcomes,” says Scott Pippin, Territory Manager for Boston Scientific. “The medical device community has very high expectations for therapies like the WATCHMANTM as an alternative treatment for patients. ASAP-TOO marks yet another milestone that has been achieved due to this partnership.”
The minimally invasive WATCHMANTM procedure is performed in CMC’s Electrophysiology Lab, often taking less than 90 minutes. Patients are in the hospital overnight and then have a follow up visit in three months. ASAP-TOO trial patients will have additional in-office or telephone follow up appointments every six months for up to five years.
“The patients we’re seeing in this trial are the ones who need this treatment most of all,” said cardiologist Jamie Kim, MD, FACC, who conducted Ms. Hinds’ procedure. “I’m proud that the team here is dedicated to leading the way with a solution that will improve the lives of our patients.”