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

NCT07684547 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-07-10

No results posted yet for this study

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.

Conditions

  • Heart Failure - NYHA II - IV
  • Left Bundle Branch Area Pacing
  • Left Bundle Branch Block
  • Intraventricular Conduction Delay
  • Resynchronization Therapy

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.

Sponsors & Collaborators

  • Medical University of Pecs

    collaborator OTHER

  • University of Pecs

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-29
Primary Completion
2030-06-29
Completion
2031-06-29
FDA Device
Yes

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07684547 on ClinicalTrials.gov