Cardiac Implantable Electronic Device

This is a multi-center, prospective, open-label, randomized controlled trial (STEP-AF) designed to evaluate the safety of a stepwise anticoagulation strategy compared with the guideline-recommended standard anticoagulation regimen in patients with non-valvular atrial fibrillation at high thromboembolic risk (CHA₂DS₂-VASc score ≥2) undergoing cardiac implantable electronic device (CIED) implantation. A total of 424 eligible patients will be randomized 1:1 to either the stepwise anticoagulation group (reduced-dose NOAC from 24 hours post-surgery to day 7, followed by standard-dose NOAC) or the standard anticoagulation group (standard-dose NOAC resumed 24 hours post-surgery). The primary endpoint is the incidence of clinically significant pocket hematoma within 30 days after surgery. Secondary endpoints include individual components of the primary endpoint and other composite outcomes of major perioperative bleeding events. The study aims to provide evidence-based data for optimizing perioperative anticoagulation regimens in Chinese patients undergoing CIED implantation.

Each year about 37,000 patients undergo a catheter ablation to treat cardiac arrhythmias or have a cardiac device such as a pacemaker or implantable cardioverter defibrillator implanted in the Netherlands. Although the procedures positively impact health related outcomes on the long term, they are often accompanied by periprocedural pain and anxiety on a shorter term. These negative effects can be prevented or treated by pharmacological interventions (e.g. analgesics or benzodiazepines), but side effects of these drugs may compromise patient safety and extend hospital admissions. Distraction using Virtual Reality (VR) may be an attractive non-pharmacological alternative. It is the aim of the Virtual Reality in Electrophysiological Procedures and device implantation (VR inEP) trial to study the feasibility and efficacy of VR to decrease experienced pain and anxiety in patients undergoing invasive procedures for arrhythmias and conduction disorders. The study also serves as a stepping stone towards structural implementation of VR into clinical care, by familiarizing care personnel of the cardiac catheterization rooms with the use of VR, its indications and logistics, and identifying potential barriers for structural implementation of VR. VR inEP is a single-center, open label, randomized controlled trial performed in the catheterization rooms in the Radboudumc. Adult patients undergoing an electrophysiological procedure (e.g., catheter ablation or electrophysiological study) or cardiac device implantation (e.g., pacemaker or implantable cardioverter defibrillator) performed under local anesthesia are eligible for inclusion. Patients consenting to participate are randomized in a 1:1 ratio to the VR intervention or control group, stratified for the indication for the procedure (50% electrophysiological procedures, 50% cardiac device implantations). Patients and their treatment teams are unblinded for the treatment allocation. The primary outcomes are pain perception and anxiety during the procedure as a whole, quantified using the visual analog scale (VAS) for pain and the numeric ranking scale (NRS) for anxiety, 30 minutes after the procedure ends.