Left Bundle Branch Area Pacing Using Conventional Stylet-driven Pacemaker Leads for Cardiac Resynchronization Therapy

Last updated: September 20, 2024
Sponsor: AZ Sint-Jan AV
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

Biventricular pacing (BiV)

Left Bundle Branch Area Pacing (LBBAP)

Clinical Study ID

NCT05365568
LeCaRT
  • Ages > 18
  • All Genders

Study Summary

The aim of this study proposal is to compare the effectiveness of two distinct pacing modalities for cardiac resynchronization therapy. Our primary hypothesis is that left bundle branch area pacing (LBBAP) using conventional stylet driven pacemaker leads is an effective resynchronization method that yield to at least similar clinical benefits and outcomes when compare to biventricular pacing.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 18 or above

  • Left Ventricular Ejection Fraction (LVEF) and NYHA meeting one off the previousindications documented with transthoracic echocardiography (TTE) no later than 3months before randomization.

  • New York Heart Association (NYHA) class II-IV

  • Baseline left bundle branch block and QRS >130ms or QRS >150ms of any morphology or a wide paced QRS duration.

Exclusion

Exclusion Criteria:

  • Younger than 18 years old

  • Pregnancy

  • Any unstable medical condition, life expectancy < 12 months

  • Inability to provide consent or to undergo follow-up

  • Narrow QRS duration (≤130ms) or prolonged QRS duration with typical Right BundleBranch Block (RBBB) morphology on 12 lead ECG and sinus rhythm.

  • Significant hypertrophic cardiomyopathy - any septum abnormality contra-indicatingLBBAP implantation (according to physician's evaluation)

  • Patients who are unable to perform a 6 minute walk test (6MWT) Note: patients shouldbe able to perform a 6 minute walk test, but it is not a requirement to have thetest performed before the procedure (e.g. due to inability of planning).

Study Design

Total Participants: 170
Treatment Group(s): 2
Primary Treatment: Biventricular pacing (BiV)
Phase:
Study Start date:
September 01, 2022
Estimated Completion Date:
September 30, 2028

Study Description

Recently some retrospective or uncontrolled studies were published that compared cardiac resynchronization therapy (CRT) using left bundle branch area pacing (LBBAP) and biventricular pacing (BiV), although with a limited number of patients. Moreover, only one of these studies compared LBBAP + right ventricle stimulation to conventional BiV stimulation prospectively. None of the studies used conventional stylet-driven pacemaker leads for LBBAP. Therefore, the present trial aims to fill-in the gap in the current literature regarding LBBAP for CRT and provide a first randomized head-to-head comparison against CRT.

The aim of this study proposal is to compare the effectiveness of two distinct pacing modalities for cardiac resynchronization therapy. Our primary hypothesis is that left bundle branch area pacing (LBBAP) using conventional stylet driven pacemaker leads is an effective resynchronization method that yields to at least similar clinical benefits and outcomes when compared to biventricular pacing.

The study is a multicentre, randomized trial comparing LBBAP against biventricular pacing. After characterization of the type device implanted (Pacing or Defibrillator), randomization will occur between both groups in a 1:1 ratio. The trial purpose is to demonstrate the efficacy of LBBAP to treat clinical heart failure in-patient indicated to receive a CRT.

Connect with a study center

  • UZA

    Edegem, Antwerpen 2650
    Belgium

    Site Not Available

  • CHU Charleroi

    Lodelinsart, Henegouwen 6042
    Belgium

    Site Not Available

  • Jessa Ziekenhuis Hasselt

    Hasselt, Limburg 3500
    Belgium

    Site Not Available

  • UZ Gent

    Gent, Oost-Vlaanderen 9000
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, Vlaams-Brabant 3000
    Belgium

    Site Not Available

  • UCL Saint-Luc

    Woluwe-Saint-Lambert, Vlaams-Brabant 1200
    Belgium

    Site Not Available

  • Clinique Saint-Pierre Ottignies

    Ottignies-Louvain-la-Neuve, Waals-Brabant 1340
    Belgium

    Site Not Available

  • AZ Sint-Jan Brugge

    Brugge, West-Vlaanderen 8000
    Belgium

    Site Not Available

  • AZ Delta

    Roeselare, West-Vlaanderen 8800
    Belgium

    Site Not Available

  • CHU HELORA - Site Jolimont

    Haine-Saint-Paul, 7100
    Belgium

    Site Not Available

  • CHR Citadelle Liège

    Liège, 4000
    Belgium

    Site Not Available

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