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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBBAP | Experimental |
| |
| BiV | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left Bundle Branch Area Pacing (LBBAP) | Procedure | Left bundle branch area pacing using conventional stylet driven pacemaker leads for cardiac resynchronization therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of procedural characteristics: Operative and fluoroscopic times | Improvement of procedural characteristics: Operative and fluoroscopic times | 1 day |
| Correction of electrical desynchrony post-implant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Benoît le Polain de Waroux, MD, PhD | AZ Sint Jan Brugge AV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZA | Edegem | Antwerpen | 2650 | Belgium | ||
| CHU Charleroi |
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| Biventricular pacing (BiV) | Procedure | Cardiac resynchronization therapy (CRT) using biventricular pacing (BiV) |
|
Correction of electrical desynchrony post-implant, at 1/6/12 months
| 1/6/12 months |
| 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 |
| 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 |
| Implantable cardioverter defibrillator (ICD) therapies | ICD therapies at 6 and 12 months | 6/12 months |
| Lodelinsart |
| Henegouwen |
| 6042 |
| Belgium |
| Jessa Ziekenhuis Hasselt | Hasselt | Limburg | 3500 | Belgium |
| CHR Citadelle Liège | Liège | Liège | 4000 | Belgium |
| UZ Gent | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| UZ Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
| UCL Saint-Luc | Woluwe-Saint-Lambert | Vlaams-Brabant | 1200 | Belgium |
| Clinique Saint-Pierre Ottignies | Ottignies-Louvain-la-Neuve | Waals-Brabant | 1340 | Belgium |
| AZ Sint-Jan Brugge | Bruges | West-Vlaanderen | 8000 | Belgium |
| AZ Delta | Roeselare | West-Vlaanderen | 8800 | Belgium |
| CHU HELORA - Site Jolimont | Haine-Saint-Paul | 7100 | Belgium |
| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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