Mielec

Researchers are evaluating two treatment methods for patients with functional Atrioventricular Block (AVB): standard elective pacemaker (PM) therapy following guidelines versus a strategy involving cardiovascular autonomic tests, electrophysiologic assessment, and cardioneuroablation (CNA). The study aims to determine if functional AVB can be effectively treated without implanting a pacemaker and to assess the safety and feasibility of CNA, potentially avoiding long-term pacing complications and costs. This trial will also validate European Society of Cardiology recommendations and introduce CNA as a treatment option for functional AVB. The trial will enroll at least 100 participants aged 18 to 75 with indications for elective pacemaker implantation and positive atropine tests. Participants will be randomly assigned to either receive optimized guideline-recommended PM therapy or undergo cardiovascular autonomic testing, electrophysiologic studies, and CNA if appropriate. Those opting out of randomization will enter a registry with individualized treatment options including PM, CNA, or observation. Treatment includes pacemaker implantation or CNA performed under general anesthesia with advanced mapping and vagal nerve stimulation guidance, followed by regular telemonitoring using ECG devices and implantable loop recorders. Participants will be monitored for a minimum of 12 months with scheduled visits at baseline, 3, 6, and 12 months including quality of life and symptom questionnaires, cardiovascular autonomic testing, and telemedical ECG monitoring. Safety will be assessed monthly with monitoring for major adverse cardiovascular events. Data collected will include demographic, clinical, and telemonitoring parameters. Patients can withdraw at any time without affecting their care. This study compares the effectiveness of CNA versus pacemaker therapy over 12 months after device implantation or procedure.

Researchers are evaluating the effect of abelacimab compared to a placebo in patients with atrial fibrillation (AF) who are considered unsuitable for oral anticoagulation therapy. This study focuses on people at high risk for ischemic stroke or systemic embolism and aims to assess the safety and effectiveness of abelacimab in preventing these events. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving patients with AF who have specific risk factors and treatment challenges. Participants will receive either abelacimab, provided as a liquid in vials at 150 mg/mL, or a matching placebo liquid. The study design includes parallel groups with blinded treatment assignment. The trial does not describe additional treatment phases or extensions but focuses on the comparison of abelacimab and placebo over the study duration. During the study, participants will be monitored for up to 30 months to measure the time until the first occurrence of ischemic stroke or systemic embolism, as well as the time until the first occurrence of serious bleeding as defined by the Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding. Safety and efficacy will be closely evaluated, with ongoing assessments to track these outcomes throughout the follow-up period.