Mielec

Researchers are evaluating two different approaches to treat functional Atrio-Ventricular Block AVB, a heart condition affecting electrical conduction. This trial compares the usual elective pacemaker PM implantation recommended by guidelines with a newer method involving cardiovascular autonomic tests CAT, electrophysiologic assessment EPS, and a procedure called cardioneuroablation CNA. The study aims to see if CNA can safely and effectively treat AVB without the need for a permanent pacemaker, validating current recommendations and exploring an alternative treatment option. The trial will include at least 100 participants aged 18 to 75 with AVB and a positive atropine test. Participants will be randomly assigned to receive either early pacemaker implantation Group A or undergo CATEPS followed by CNA with possible delayed pacemaker implantation if needed Group B. Those opting out of randomization enter a registry with personalized treatment choices. Group A will receive pacemakers with telemonitoring, while Group B will get implantable loop recorders and undergo CNA under general anesthesia. If CNA is unsuccessful, pacemaker implantation may follow. Participants will be involved for at least 12 months, undergoing regular check-ups at baseline, 3, 6, and 12 months. Assessments include ECG telemonitoring, quality of life and symptom questionnaires, and cardiovascular autonomic tests with telemedicine support. Safety will be closely monitored monthly, focusing on major cardiovascular events. The study uses telemonitoring devices and provides 247 contact with specialized medical staff. Data on symptoms, fatigue, depression, and sleep will also be collected to evaluate treatment effects comprehensively.

Researchers are examining the effect of abelacimab compared to a placebo in patients with atrial fibrillation AF who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients with AF to evaluate whether abelacimab can reduce the occurrence of ischemic stroke or systemic embolism. The study is led by Anthos Therapeutics, Inc. and aims to address treatment options in patients where traditional anticoagulation is deemed inappropriate. Participants are randomly assigned in equal numbers to receive either abelacimab 150 mg or a matching placebo by subcutaneous injection once a month. The study consists of three periods a screening period lasting up to 60 days, a double-blind treatment period that continues until at least 111 patients experience a primary endpoint event, and an end-of-treatment visit. Following this, participants may enter a 30-day follow-up or an optional open-label extension to receive abelacimab, depending on eligibility and regulatory approval. During the study, participants undergo assessments to monitor stroke, systemic embolism, and bleeding events, with the primary outcomes measured up to 30 months. Safety is tracked by recording bleeding events classified by the Bleeding Academic Research Consortium. Secondary outcomes include cardiovascular and all-cause mortality and other thrombotic events. The study also involves regular monitoring and follow-up visits to assess efficacy and safety throughout the treatment and observation periods.