AZ Sint-Jan AV
Jean-Benoît Le Polain de Waroux
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.
Heart Failure With Reduced Ejection Fraction
Left Bundle Branch Area Pacing (LBBAP)
Biventricular pacing (BiV)
Not Applicable
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 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
UZA
Edegem, Antwerpen, Belgium, 2650
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Jessa Ziekenhuis Hasselt
Hasselt, Limburg, Belgium, 3500
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UZ Gent
Gent, Oost-Vlaanderen, Belgium, 9000
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UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
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UCL Saint-Luc
Woluwe-Saint-Lambert, Vlaams-Brabant, Belgium, 1200
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Clinique Saint-Pierre Ottignies
Ottignies-Louvain-la-Neuve, Waals-Brabant, Belgium, 1340
Recruiting
AZ Sint-Jan Brugge
Brugge, West-Vlaanderen, Belgium, 8000
Recruiting
AZ Delta
Roeselare, West-Vlaanderen, Belgium, 8800
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CHR Citadelle Liège
Liège, Belgium, 4000