Rotenburg An Der Fulda

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 evaluating the effectiveness, safety, and economic benefits of coronary lithotripsy compared to other procedures like cutting or super high pressure balloon angioplasty and ablative methods in treating severely calcified coronary artery lesions. The study focuses on patients with coronary artery disease who have severe calcification in their coronary arteries, aiming to improve the preparation and treatment of these blockages. This is a randomized, multicenter clinical trial assessing these different methods to better understand their benefits in lesion treatment. Participants receive either intravascular lithotripsy (IVL) using balloons with a burst pressure of up to 18 atmospheres or standard non-IVL methods such as special high pressure, super high pressure, cutting balloons, and ablative procedures for treating severely calcified lesions. The trial compares these treatment groups to assess additional benefits of coronary lithotripsy. Treatments are performed during the interventional procedure aimed at opening narrowed coronary arteries. During the study, participants are monitored for major cardiac and cerebrovascular events up to 12 months after randomization. Researchers will collect data on the combined endpoint of these serious events to evaluate the treatments' outcomes. Participants must meet specific eligibility criteria and provide informed consent. The study aims to provide insights into the best treatment approaches for patients with severe coronary artery calcification, with follow-up extending over one year after treatment.