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

NCT05365568 | Active Not Recruiting

• 1 other identifier: LeCaRT
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 11

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.

Conditions

Heart Failure with Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Number of days elapsed from study procedure to first occurrence of one of the following events (combined endpoint) or to study close-out in the total patient population.

  First occurrence of one of the following clinical events: death, hospitalization or unscheduled visit for heart failure (HF) or worsening HF symptoms with adaptation of the medical therapy, implant failure for any cause, implantable electronic cardiac device (IECD) re-intervention for any reason during follow-up (Lead Dislocation/phrenic nerve stimulation…)

  12 months

Secondary Outcomes (5)

• Improvement of procedural characteristics: Operative and fluoroscopic times

  1 day

• Correction of electrical desynchrony post-implant

  1/6/12 months

• Clinical functional response (6MWT)

  6 months

• Left ventricular reverse remodelling

  6/12 months

• Implantable cardioverter defibrillator (ICD) therapies

  6/12 months

Study Arms (2)

LBBAP

EXPERIMENTAL

Procedure: Left Bundle Branch Area Pacing (LBBAP)

BiV

ACTIVE COMPARATOR

Procedure: Biventricular pacing (BiV)

Interventions

Left Bundle Branch Area Pacing (LBBAP) PROCEDURE

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

LBBAP

Biventricular pacing (BiV) PROCEDURE

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

BiV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (11)

UZA

Edegem, Antwerpen, 2650, Belgium

Location

CHU Charleroi

Lodelinsart, Henegouwen, 6042, Belgium

Location

Jessa Ziekenhuis Hasselt

Hasselt, Limburg, 3500, Belgium

Location

CHR Citadelle Liège

Liège, Liège, 4000, Belgium

Location

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

UCL Saint-Luc

Woluwe-Saint-Lambert, Vlaams-Brabant, 1200, Belgium

Location

Clinique Saint-Pierre Ottignies

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

Location

AZ Sint-Jan Brugge

Bruges, West-Vlaanderen, 8000, Belgium

Location

AZ Delta

Roeselare, West-Vlaanderen, 8800, Belgium

Location

CHU HELORA - Site Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

MeSH Terms

Interventions

Cardiac Resynchronization Therapy

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Jean-Benoît le Polain de Waroux, MD, PhD

  AZ Sint Jan Brugge AV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Principal Investigator

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 9, 2022
• Study Start: September 1, 2022
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (11)