Burgau

Atrial fibrillation is a common heart rhythm disorder that increases the risk of blood clots forming in the heart, especially the left atrium. These clots can cause strokes if they travel to the brain. Patients with atrial fibrillation who have previously experienced bleeding in the brain (intracranial bleeding) face challenges in treatment, as blood thinners can prevent clots but also increase bleeding risk. This research compares two approved treatment methods for such patients: a device to close the left atrial appendage (LAA) and oral blood-thinning medications (anticoagulants). One group of patients will receive a procedure to close the LAA using a device called Watchman or Watchman FLX, performed by skilled doctors under imaging guidance. After this procedure, patients usually take aspirin and clopidogrel for three months, followed by aspirin alone for up to a year. Alternatively, some may receive three months of oral anticoagulants followed by aspirin. The other group will continue oral anticoagulation therapy with medications that reduce stroke risk but have bleeding considerations. The study uses only approved devices and medications. Participants will be monitored for up to three years to track events such as cardiovascular death, stroke, embolism, and bleeding complications. Researchers will assess these outcomes to understand the benefits and risks of each treatment. The study aims to provide important data to guide doctors in managing atrial fibrillation patients with prior brain bleeding and to help reduce mortality and complications in this high-risk group.

Researchers are studying patients with Disorders of Consciousness (DoC) following severe acquired brain injury to explore how spontaneous eye blinking features, such as rate, amplitude, duration, and variability, can help distinguish between Unresponsive Wakefulness Syndrome (UWS) and Minimally Conscious State (MCS). This observational, multicenter study takes place across nine European centers and aims to assess the diagnostic and prognostic value of these eye blink parameters in patients with severe brain injuries. The study plans to enroll 70 patients with DoC and 23 healthy volunteers to serve as a comparison group. Patients will undergo two 20-minute resting EEG-EOG recording sessions within two weeks of enrollment, spaced 24 hours apart. The recordings will be done with patients awake and in a quiet, dimly lit environment, monitored by researchers who will encourage relaxation with eyes open. If patients are not sufficiently alert, an arousal facilitation protocol will be used or the session rescheduled. Healthy volunteers will also complete two similar EEG-EOG sessions. The study follows routine clinical practice and patients will be followed up six months after enrollment. During the study, researchers will collect clinical data, perform repeated consciousness assessments using the Coma Recovery Scale-Revised, and analyze eye blink activity from EEG-EOG recordings to investigate relationships with consciousness levels. The main outcome is the clinical diagnosis at six months. The study duration is about 24 months, including 12 months for enrollment, with data collected transparently and safely across multiple centers.