Clinical trial NCT05365568: Left Bundle Branch Area Pacing Using Conventional Stylet-driven Pacemaker Leads for Cardiac Resynchronization Therapy
Official title: Left Bundle Branch Area Pacing Using Conventional Stylet Driven Pacemaker Leads for Cardiac Resynchronization Therapy: a Randomized Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure with Reduced Ejection Fraction
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 \&amp;amp;amp;gt;130ms or QRS \&amp;amp;amp;gt;150ms of any morphology or a wide paced QRS duration.

Exclusion Criteria:

* Younger than 18 years old
* Pregnancy
* Any unstable medical condition, life expectancy \&amp;amp;amp;lt; 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).

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: Improvement of procedural characteristics: Operative and fluoroscopic times
timeFrame: 1 day
measure: Correction of electrical desynchrony post-implant
timeFrame: 1/6/12 months
measure: Clinical functional response (6MWT)
timeFrame: 6 months
measure: Left ventricular reverse remodelling
timeFrame: 6/12 months
measure: Implantable cardioverter defibrillator (ICD) therapies
timeFrame: 6/12 months
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: UZA
state: Antwerpen
city: Lodelinsart
country: Belgium
facility: CHU Charleroi
state: Henegouwen
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis Hasselt
state: Limburg
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
city: Woluwe-Saint-Lambert
country: Belgium
facility: UCL Saint-Luc
state: Vlaams-Brabant
city: Ottignies-Louvain-la-Neuve
country: Belgium
facility: Clinique Saint-Pierre Ottignies
state: Waals-Brabant
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge
state: West-Vlaanderen
city: Roeselare
country: Belgium
facility: AZ Delta
state: West-Vlaanderen
city: Haine-Saint-Paul
country: Belgium
facility: CHU HELORA - Site Jolimont
city: Liège
country: Belgium
facility: CHR Citadelle Liège
Study officials:
affiliation: AZ Sint Jan Brugge AV
name: Jean-Benoît le Polain de Waroux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: