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

NCT ID: NCT05365568

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2028-09-30

Brief 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.

Detailed 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.

Conditions

Heart Failure with Reduced Ejection Fraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LBBAP

Group Type: EXPERIMENTAL

Left Bundle Branch Area Pacing (LBBAP)

Intervention Type: PROCEDURE

Left bundle branch area pacing using conventional stylet driven pacemaker leads for cardiac resynchronization therapy

BiV

Group Type: ACTIVE_COMPARATOR

Biventricular pacing (BiV)

Intervention Type: PROCEDURE

Cardiac resynchronization therapy (CRT) using biventricular pacing (BiV)

Interventions

Left Bundle Branch Area Pacing (LBBAP)

Left bundle branch area pacing using conventional stylet driven pacemaker leads for cardiac resynchronization therapy

Intervention Type: PROCEDURE

Biventricular pacing (BiV)

Cardiac resynchronization therapy (CRT) using biventricular pacing (BiV)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Aged 18 or above
• Left Ventricular Ejection Fraction (LVEF) and NYHA meeting one off the previous indications documented with transthoracic echocardiography (TTE) no later than 3 months 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 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 Bundle Branch Block (RBBB) morphology on 12 lead ECG and sinus rhythm.
• Significant hypertrophic cardiomyopathy - any septum abnormality contra-indicating LBBAP implantation (according to physician's evaluation)
• Patients who are unable to perform a 6 minute walk test (6MWT) Note: patients should be able to perform a 6 minute walk test, but it is not a requirement to have the test performed before the procedure (e.g. due to inability of planning).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AZ Sint-Jan AV

OTHER

Sponsor Role: lead

Responsible Party

Jean-Benoît Le Polain de Waroux

Coordinating Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean-Benoît le Polain de Waroux, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AZ Sint Jan Brugge AV

Locations

UZA

Edegem, Antwerpen, Belgium

CHU Charleroi

Lodelinsart, Henegouwen, Belgium

Jessa Ziekenhuis Hasselt

Hasselt, Limburg, Belgium

CHR Citadelle Liège

Liège, Liège, Belgium

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

UCL Saint-Luc

Woluwe-Saint-Lambert, Vlaams-Brabant, Belgium

Clinique Saint-Pierre Ottignies

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

AZ Sint-Jan Brugge

Bruges, West-Vlaanderen, Belgium

AZ Delta

Roeselare, West-Vlaanderen, Belgium

CHU HELORA - Site Jolimont

Haine-Saint-Paul, , Belgium

Countries

Belgium

Other Identifiers

LeCaRT

Identifier Type: -

Identifier Source: org_study_id