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NOT YET RECRUITING
NCT07684547

REstoration of SYNChronous Cardiac Function Due to Physiologic cArdiac Pacing Modalities With Clinical Endpoints

Sponsor: University of Pecs

View on ClinicalTrials.gov

Summary

The goal of this observational study is to evaluate the long-term clinical outcomes of physiologic cardiac resynchronization therapy (CRT) using conduction system pacing strategies compared with conventional biventricular CRT in patients with heart failure with reduced ejection fraction (HFrEF) and electrical dyssynchrony. The main questions it aims to answer are: * Does physiologic CRT (including left bundle branch area pacing \[LBBAP\] and LBBAP-optimized CRT) reduce the combined risk of all-cause mortality and heart failure hospitalization compared with conventional biventricular CRT? * Does physiologic CRT improve cardiac function and reverse ventricular remodeling more effectively than conventional CRT? Participants receiving physiologic CRT as part of routine clinical care will undergo standard follow-up evaluations, including electrocardiography, echocardiography, laboratory testing, and device interrogation. Clinical outcomes will be collected prospectively for 24 months and compared with a historical cohort of patients treated with conventional biventricular CRT. The study will assess clinical outcomes, echocardiographic response, electrical resynchronization parameters, and device-related safety in a real-world heart failure population.

Official title: REstoration of SYNChronous Cardiac Function Due to Physiologic cArdiac Pacing Modalities With Clinical Endpoints RESYNC-PACE

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2026-06-29

Completion Date

2031-06-29

Last Updated

2026-07-10

Healthy Volunteers

No

Interventions

DEVICE

Physiologic cardiac resynchronization using conduction system pacing and selective LV lead optimization.

Conduction System Pacing-Guided Cardiac Resynchronization Therapy is an individualized resynchronization strategy used in patients with heart failure, reduced left ventricular ejection fraction, and electrical dyssynchrony. The intervention is based on direct recruitment of the native cardiac conduction system through left bundle branch area pacing (LBBAP). During implantation, electrical resynchronization is assessed using electrocardiographic and device-derived parameters. In patients with intraventricular conduction delay or incomplete electrical correction, additional left ventricular pacing may be provided using a coronary sinus lead, resulting in Left Bundle Branch Area Pacing Optimized Cardiac Resynchronization Therapy (LOT-CRT). The intervention aims to achieve more physiological ventricular activation than conventional biventricular pacing, improve electrical synchrony, promote reverse ventricular remodeling, and reduce heart failure-related adverse events.

Locations (1)

Heart Institute , University of Pécs

Pécs, Baranya, Hungary