LBBP + CSP Versus LBBP Alone for Cardiac Resynchronization Therapy

The purpose of this pilot clinical trial is to evaluate whether a novel cardiac resynchronization strategy, called LOT-CRT, is more effective than standard physiological pacing alone (LBBAP) in patients with heart failure. This is a randomized, single-center, crossover pilot study involving 10 patients. All participants will receive a specialized pacemaker (CRT-P) with leads implanted in two specific areas: the Left Bundle Branch Area (LBBAP) and the Coronary Sinus (CS). Because of the crossover design, each patient will serve as their own control, receiving two different pacing configurations in a random order: Active Phase (LOT-CRT): Simultaneous pacing of the left bundle branch and the coronary sinus. Control Phase (LBBAP alone): Pacing only the left bundle branch area. Each treatment phase will last 6 months, for a total follow-up of 12 months per patient. By testing both strategies in the same patient, this study will help clinicians identify the most effective way to restore heart synchrony and improve clinical outcomes in patients with advanced heart failure and conduction delays.

NCT Number	NCT07664189
Lead Sponsor	Clinica Cardio VID
Conditions	Heart Failure Low Output
Enrollment	10 participants
Start Date	2026-06-09
Primary Completion	2027-07-01 (estimated)
Study Completion	2027-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-23