Left Bundle Branch Area Pacing for Cardiac Resynchronization Therapy: A Randomized Study

Heart Failure With Reduced Ejection Fraction Clinical Trial

— LeCaRT  

Official title:

Left Bundle Branch Area Pacing Using Conventional Stylet Driven Pacemaker Leads for Cardiac Resynchronization Therapy: A Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05365568
• Other study ID #: V1.0_20220328
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: October 2022
• Source: AZ Sint-Jan AV
• Contact: Jean-Benoît le Polain de Waroux, MD, PhD
• Phone: +32 50 45 26 70
• Email: Jean-Benoit.LePolainDeWaroux[@]AZsintjan.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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:

• < 18 years age
• 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).

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Procedure:
• Left Bundle Branch Area Pacing (LBBAP)
Left bundle branch area pacing using conventional stylet driven pacemaker leads for cardiac resynchronization therapy
• Biventricular pacing (BiV)
Cardiac resynchronization therapy (CRT) using biventricular pacing (BiV)

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan Brugge	Brugge	West-Vlaanderen
Belgium	UZA	Edegem	Antwerpen
Belgium	UZ Gent	Gent	Oost-Vlaanderen
Belgium	Jessa Ziekenhuis Hasselt	Hasselt	Limburg
Belgium	UZ Leuven	Leuven	Vlaams-Brabant
Belgium	CHR Citadelle Liège	Liège
Belgium	Clinique Saint-Pierre Ottignies	Ottignies-Louvain-la-Neuve	Waals-Brabant
Belgium	AZ Delta	Roeselare	West-Vlaanderen
Belgium	UCL Saint-Luc	Woluwe-Saint-Lambert	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement of procedural characteristics: Operative and fluoroscopic times	Improvement of procedural characteristics: Operative and fluoroscopic times	1 day
Secondary	Correction of electrical desynchrony post-implant	Correction of electrical desynchrony post-implant, at 1/6/12 months	1/6/12 months
Secondary	Clinical functional response (6MWT)	Clinical functional response as evaluated by the improvement of the 6 Minutes Walk Test (6MWT) at 6 months follow-up	6 months
Secondary	Left ventricular reverse remodelling	Left ventricular reverse remodelling at 6 and 12 months follow-up as evaluated by the reduction of the Left Ventricular End-systolic Volume (LVESV) using trans-thoracal echocardiography	6/12 months
Secondary	Implantable cardioverter defibrillator (ICD) therapies	ICD therapies at 6 and 12 months	6/12 months