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NCT05365568 | Recruiting | Heart Failure With Reduced Ejection Fraction


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

AZ Sint-Jan AV

Information provided by (Responsible Party):

Jean-Benoît Le Polain de Waroux

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.

Condition or disease

Heart Failure With Reduced Ejection Fraction

Intervention/treatment

Left Bundle Branch Area Pacing (LBBAP)

Biventricular pacing (BiV)

Phase

Not Applicable

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.

Study Type : Interventional
Estimated Enrollment : 170 participants
Masking: Single
Primary Purpose: Treatment
Official Title: Left Bundle Branch Area Pacing Using Conventional Stylet Driven Pacemaker Leads for Cardiac Resynchronization Therapy: A Randomized Study
Actual Study Start Date : September 1, 2022
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2024
Arm Intervention/treatment

Experimental: LBBAP for CRT-p

Procedure: Left Bundle Branch Area Pacing (LBBAP)

Experimental: LBBAP for CRT-d

Procedure: Left Bundle Branch Area Pacing (LBBAP)

Active Comparator: BiV for CRT-p

Procedure: Biventricular pacing (BiV)

Active Comparator: BiV for CRT-d

Procedure: Biventricular pacing (BiV)

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
  • < 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).

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

Location Details


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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Belgium, Antwerpen

UZA

Edegem, Antwerpen, Belgium, 2650

Not yet recruiting

Belgium, Limburg

Jessa Ziekenhuis Hasselt

Hasselt, Limburg, Belgium, 3500

Not yet recruiting

Belgium, Oost-Vlaanderen

UZ Gent

Gent, Oost-Vlaanderen, Belgium, 9000

Not yet recruiting

Belgium, Vlaams-Brabant

UZ Leuven

Leuven, Vlaams-Brabant, Belgium, 3000

Not yet recruiting

Belgium, Vlaams-Brabant

UCL Saint-Luc

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

Not yet recruiting

Belgium, Waals-Brabant

Clinique Saint-Pierre Ottignies

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

Recruiting

Belgium, West-Vlaanderen

AZ Sint-Jan Brugge

Brugge, West-Vlaanderen, Belgium, 8000

Recruiting

Belgium, West-Vlaanderen

AZ Delta

Roeselare, West-Vlaanderen, Belgium, 8800

Not yet recruiting

Belgium,

CHR Citadelle Liège

Liège, Belgium, 4000

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