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Conduction System Pacing Versus Biventricular Pacing for Cardiac ResYNChronization

NCT05155865 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2024-11-01

No results posted yet for this study

Summary

Cardiac resynchronization therapy (CRT) with biventricular pacing (BiV) is the cornerstone treatment for heart failure patients with ventricular dyssynchrony. Recently, a new concept, conduction system pacing (CSP) with permanent pacing, including His bundle pacing and left bundle branch pacing, has been proposed as a potential alternative to conventional BiV-CRT. The prospective, randomized trial will compare echocardiographic, electrocardiographic, and clinical effects of CSP versus conventional BiV pacing in heart failure patients with reduced ejection fraction (LVEF ≤ 35%), sinus rhythm, and left bundle branch block. Patients will be randomized to either CSP or biventricular pacing study group and followed up for at least 6 months. The study will explore whether CSP is non-inferior to BiV pacing in echocardiographic, electrocardiographic, and clinical outcomes.

Conditions

  • Dilated Cardiomyopathy with Conduction Defect
  • Left Bundle-Branch Block
  • Heart Failure
  • Resynchronization Therapy
  • Cardiac Remodeling, Ventricular

Interventions

DEVICE

Resynchronization with conduction system pacing

Implantation of permanent pacemaker with conduction system pacing (preferably left bundle branch) with or without defibrillator lead placement

DEVICE

Cardiac resynchronization therapy with biventricular stimulation

Implantation of cardiac resynchronization therapy with biventricular stimulation with or without defibrillator lead placement

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Marta Cvijc, MD · University Medical Centre Ljubljana (Slovenia)

  • Anja Zupan Meznar, MD · University Medical Centre Ljubljana (Slovenia)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2024-10-28
Completion
2024-10-28

Countries

  • Slovenia

Study Locations

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Entities

Diseases

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 NCT05155865 on ClinicalTrials.gov