Nordic Randomized Trial Comparing Conduction System Pacing with Conventional Biventricular Pacing for Heart Failure Patients Requiring Cardiac Resynchronization Therapy

What this Trial Is About

The trial investigates conduction system pacing CSP compared to conventional biventricular pacing for patients with heart failure needing cardiac resynchronization therapy CRT. It focuses on whether HIS bundle pacing or left bundle branch pacing can better reduce the risk of death or unplanned heart failure hospitalizations in patients with reduced heart function LVEF 35% and CRT indications. This randomized controlled trial is conducted across centers in Nordic countries with experience in CSP. Participants are randomly assigned to receive either CSP via HIS or LBB pacing or conventional biventricular pacing. The implantation procedure varies by group CSP involves positioning leads at the HIS or left bundle branch areas using specific criteria and equipment, while conventional pacing uses a left ventricular lead placed in a coronary sinus branch. Device implantation and lead placement are tailored to patient anatomy and operator judgment, with cross-over allowed if CSP is unsuccessful. Follow-up includes device checks and clinical assessments at 3, 6, 12 months, and annually, with echocardiographic and walking tests scheduled at 6 and 24 months. Participants undergo evaluations including ECGs, echocardiograms, blood tests, and questionnaires on quality of life and symptoms. Remote monitoring is used for all patients. Researchers measure the occurrence of death or heart failure hospitalizations, device-related complications, heart function changes, walking ability, neurohormone levels, arrhythmias, and device performance over at least 2 years. The study includes detailed monitoring of implantation time, x-ray use, and electrode function to assess safety and effectiveness of the pacing methods.

Conduction System Pacing vs. Biventricular Pacing for Cardiac Resynchronization Therapy