Randomized Comparison of Left Atrial Appendage Closure Device Versus Oral Anticoagulation Therapy in Patients With Non-valvular Atrial Fibrillation and Prior Intracranial Bleeding

What this Trial Is About

Atrial fibrillation is a common heart rhythm disorder that increases the risk of blood clots forming in the heart, which can lead to stroke. Patients who have had a stroke caused by bleeding in the brain intracranial bleeding face challenges with blood-thinning medications because these can cause further bleeding. This research compares two approved treatments to prevent stroke in such patients oral anticoagulation medications and a device that closes off a part of the heart called the left atrial appendage LAA. One group of patients will receive a minimally invasive procedure to close the LAA using a CE-marked device called Watchman or Watchman FLX. After closure, patients typically take aspirin and clopidogrel for three months, followed by aspirin alone for up to a year. Alternatively, some may take a short course of anticoagulants before aspirin. The other group will be treated with standard oral anticoagulation therapy as recommended by current guidelines. This study is randomized to fairly compare these two approaches for stroke prevention in patients with atrial fibrillation and prior brain bleeding. Participants will be followed for up to three years after treatment to monitor important outcomes such as survival free from stroke, systemic embolism, cardiovascular death, and bleeding events. Researchers will conduct evaluations to track these events and assess overall safety. The study aims to provide data to guide doctors in choosing the best prevention strategy for stroke in patients with atrial fibrillation who have experienced intracranial bleeding, potentially improving management and outcomes over time.

Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.