Clinical trials

This study will compare the amount of cerebral microembolization during transcatheter aortic valve implantation (TAVI) between two commonly used types of transcatheter aortic valves: balloon-expandable valves and self-expanding valves. Cerebral microembolization refers to small particles or material that may travel to the brain during the procedure. These signals can be detected using transcranial Doppler ultrasound, a non-invasive method for monitoring blood flow in the brain. Although clinically apparent stroke after TAVI is relatively uncommon, small silent brain lesions may occur, and their mechanisms are not fully understood. Adult patients with severe symptomatic aortic valve stenosis who are scheduled for TAVI will be included. Participants will be randomly assigned to receive either a balloon-expandable or a self-expanding valve, both of which are established and routinely used treatment options. Transcranial Doppler monitoring will be performed before, during, and after the procedure to record the number of microembolic signals. The study will also record neurological events and procedural characteristics, such as procedure duration and the need for balloon dilatation. The aim of the study is to determine whether the type of valve is associated with a different burden of cerebral microembolization during TAVI. The results may help improve understanding of procedural factors related to cerebral embolization and may support future strategies for reducing neurological risk in patients undergoing TAVI.

This prospective, randomized, parallel-group interventional study will compare cerebral microembolization during pulmonary vein isolation between different pulsed field ablation systems in patients with paroxysmal or persistent atrial fibrillation. Adult patients with an indication for catheter ablation will be randomized to one of the included ablation systems: PulseSelect, Varipulse, Farapulse, Sphere-9, or Sphere-360. Microembolic signals will be assessed using transcranial Doppler before and after the procedure. The primary outcome will be the difference in the change in microembolic signal burden, expressed as ΔMES, between the different ablation systems.

This study evaluates whether re-sterilized (reprocessed) ablation catheters are as effective and safe as new ablation catheters when used for electrophysiological procedures. Adult patients scheduled for catheter ablation will be randomly assigned to undergo the procedure using either a new catheter or a re-sterilized catheter, with identical procedural techniques applied in both groups. The study will compare procedural efficiency, safety, costs, and environmental impact between the two approaches. The results may support more sustainable and cost-effective use of medical devices in cardiac electrophysiology.