Local Medical Center Enrolls First Michigan Patient in Advanced Clinical Trial
MidMichigan Medical Center – Midland recently enrolled the first Michigan patient in the OPTION clinical trial study. The Medical Center is one of only two locations in the state of Michigan and one of 86 total sites currently participating in this international study sponsored by Boston Scientific. The goal of the OPTION study, which is currently enrolling 1600 patients globally, is to determine if left atrial appendage closure with the WATCHMAN FLX™ device (an improved device which may improve safety during implantation) is a reasonable alternative to oral anticoagulation for high risk patients following ablation for non-valvular atrial fibrillation.
“Cardiac ablation is an effective way to treat an abnormal heart rhythm for many patients, though symptomatic relief can lead these patients to stop taking their blood thinners and unknowingly put themselves at an elevated risk for a stroke,” said Nilofar Islam, M.D., F.A.C.C., director of electrophysiology at MidMichigan Medical Center – Midland. “Blood thinners also have side effects of increased bleeding events over time. The WATCHMAN FLX implantation allows for safe discontinuation of blood thinners. It may become the standard of care for ablation patients in the future.”
Patients who meet criteria and consent to this clinical study will be randomly assigned to either continue their prescribed oral anticoagulation medication or undergo implantation of the WATCHMAN FLX device. All study patients will be followed for 36 months to assess further symptoms.
“In recent years, the number of U.S. patients who have undergone an in-hospital cardiac ablation procedure to prevent abnormal electrical signals from moving through the heart has grown tenfold,” said Dr. Islam. “More than 50 percent of those patients become asymptomatic, making them less likely to adhere to current guidelines recommending the continuation of oral anticoagulation post-procedure to reduce the risk of stroke. Stroke is five times more likely to occur in patients with AF than in someone with a normal heart rhythm, even if the atrial fibrillation (AF) episode is brief.”
Currently 33 million people have AF worldwide. MidMichigan’s involvement in advanced clinical trials like the OPTION study provides opportunities for local patients to have access to leading-edge innovation in heart care close to home.
“MidMichigan Health is committed to improving patient care and investing in innovative medical technology such as the WATCHMAN and WATCHMAN FLX devices,” said Sunita Vadakath, M.D., F.R.C.A., M.P.A., vice president of service lines for MidMichigan Health. “Our Clinical Research Department and physicians are very excited to be on the forefront of bringing new pharmaceutical and advanced medical technologies to patients across the communities we serve.”
Those who would like more information on MidMichigan’s Heart Valve Clinic may visit www.midmichigan.org/heartvalveclinic. Additional information about clinical trials can be found at www.midmichigan.org/clinicaltrials.
WATCHMAN FLX is a trademark of Boston Scientific.