Trial Comparing Modern Physiological Pacing to Traditional Right Ventricular Pacing for Patients with Heart Failure and Pacemakers

What this Trial Is About

Researchers are evaluating pacing methods to improve symptoms and quality of life for patients with pacemakers. This trial focuses on patients who have a traditional right ventricular RV pacemaker and impaired heart function, testing whether switching to a modern physiological pacing strategy can provide better outcomes. The study is a crossover trial comparing physiological pacing methods to continued RV pacing in patients with pacing-induced cardiomyopathy and heart failure. Participants will first undergo an upgrade procedure to physiological pacing, which may involve His bundle pacing, left bundle pacing, or biventricular pacing if the first two approaches are not possible. After the procedure, there is a one-month recovery period with continued RV pacing. Then participants experience two one-month blinded periods alternating between physiological pacing and RV pacing, followed by two six-month blinded crossover periods. The RV pacing is performed at apical or septal lead locations as per usual practice. During the study, participants will record symptoms monthly using a mobile app or computer. At the end of each period, heart function will be assessed along with a walking test and quality-of-life questionnaires, including the SF-36 survey. Other measurements include left ventricular function, atrial fibrillation monitoring, BNP blood tests, and patient preference surveys. Safety monitoring continues throughout the study, which lasts about fourteen months from baseline to final follow-up.

Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades