Advancing Conduction System Pacing with Simplified Implant Techniques and Improved ECG Interpretation in Adults

What this Trial Is About

Researchers are studying conduction system pacing, a new method of stimulating the hearts electrical system directly to produce more natural heartbeats. This approach is compared to traditional pacemakers which stimulate the heart muscle and can cause disordered heartbeats that wear down the heart over time. The study aims to simplify the process of inserting conduction system pacemaker wires so that this treatment can be offered more widely at any hospital, not just specialized centers. It also seeks to improve the pacemakers ability to interpret electrical signals from the heart. The study involves 100 patients who need a pacemaker and will receive conduction system pacemaker implants. The first 50 patients undergo additional tests including ultra-high frequency ECG, electro-anatomical mapping, echocardiography, and blood pressure assessments to identify the best wire locations in the heart. The next 50 patients will have their pacemakers implanted using a step-by-step algorithm developed from earlier data, using standard equipment and including operators new to this implant technique. Another group of 200 patients with chronic conduction system leads will have ECG recordings taken during routine follow-ups to analyze pacing and sensing configurations. Participants will undergo imaging scans such as MRI, CT, and ultrasound, electrical measurements, and routine follow-up visits. The study measures success rates of the new implant method compared to conventional methods, procedure and fluoroscopy times, pacemaker capture thresholds, and device battery life improvements. Data collection continues until six months after the last patient is recruited, with safety and effectiveness monitored throughout the study period, which lasts about three years.

Solutions to the Challenges of Conduction System Pacing