MarinHealth Becomes the First Regional Center to Offer Patients the OPTION Trial Studying WATCHMAN FLX
MarinHealth today announced it has become the first regional hospital to offer patients the OPTION trial studying WATCHMAN FLX™. The OPTION trial is a multinational trial studying the WATCHMAN FLX device to determine whether it can reduce the risk of stroke and bleeding after catheter ablation. It is the first to study an alternative to oral anticoagulation (OAC) in post-ablation patients with increased risk of stroke.
The WATCHMAN FLX, currently investigational in the US and in clinical use in Europe, was designed to offer greater ease of deployment and the ability to fit a wider range of patient anatomy.
Atrial fibrillation, often called AFib, is the most common type of serious heart arrhythmia. It can cause substantial symptoms in affected patients, including symptoms of irregularity in the chest, palpitations, shortness of breath, and most importantly, stroke and death. According to the CDC, an estimated 2.7–6.1 million people in the United States have AFib. With the aging of the U.S. population, this number is expected to increase.
The OPTION trial will randomize 1,600 patients with non-valvular AFib who are suitable for OAC therapy and have recently had or will have an ablation. Patients at 130 global sites will be randomly assigned to receive the newest-generation WATCHMAN FLX device or an OAC, inclusive of commonly prescribed direct oral anticoagulants. The primary effectiveness endpoint is all cause of death, stroke and systemic embolism through 36 months, and the primary safety endpoint is non-procedural bleeding through 36 months.
Patient enrollments and device implants will occur at MarinHealth Medical Center. All patients with AFib in Northern California and beyond are invited to participate.
“As a leader in cardiovascular care, MarinHealth is pleased to be recognized as a regional center of excellence for the comprehensive treatment of atrial fibrillation, particularly in closure of the left atrial appendage, an important option for stroke prevention,” said Arun Raghupathy, MD, FACC at MarinHealth. “As the first center in the western United States to both enroll and implant in this trial, we are excited to offer our patients the latest and greatest in care through participation in this type of research activity.”
Many patients have been effectively treated for their AFib with catheter ablation but remain at risk for stroke and thus remain on blood thinners. Use of blood thinners (anticoagulant medications) represent a major source of complications after successful AFib ablation. Problems can include bleeding and poor tolerance of medications.
“Participation in this clinical trial offers the potential to discontinue these medications, which can be a source of substantial morbidity and side effects,” Raghupathy said.
To learn more about the Watchman Implant procedure at MarinHealth, visit: https://www.mymarinhealth.org/programs-services/cardiovascular-medicine/structural-heart-program/watchman-implant/
For patient referrals and for further information, please contact:
- Primary investigator Vivek Iyer, MD
- Clinical Research Coordinator Liliana Espinosa Bonell: research@mymarinhealth.org
About MarinHealth
MarinHealth is a collaboration of respected healthcare resources that have served our community well for decades. The MarinHealth entities (Medical Center, Foundation, and Medical Network) work closely to deliver coordinated, patient-centric care to the people of Marin and the greater North Bay. Residents count on MarinHealth for access to expert physicians and providers, advanced treatments and technology, and a common commitment to provide outstanding care for our patients, body, mind, and spirit.
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