Left Bundle Branch Area Pacing Using Conventional Stylet-driven Pacemaker Leads for Cardiac Resynchronization Therapy (LeCaRT)
Left Bundle Branch Area Pacing Using Conventional Stylet Driven Pacemaker Leads for Cardiac Resynchronization Therapy: a Randomized Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Haine-Saint-Paul, Belgium, 7100
- CHU Helora - Site Jolimont
-
Liège, Belgium, 4000
- CHR Citadelle Liège
-
-
Antwerpen
-
Edegem, Antwerpen, Belgium, 2650
- UZA
-
-
Henegouwen
-
Lodelinsart, Henegouwen, Belgium, 6042
- CHU Charleroi
-
-
Limburg
-
Hasselt, Limburg, Belgium, 3500
- Jessa Ziekenhuis Hasselt
-
-
Oost-Vlaanderen
-
Gent, Oost-Vlaanderen, Belgium, 9000
- UZ Gent
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Belgium, 3000
- UZ Leuven
-
Woluwe-Saint-Lambert, Vlaams-Brabant, Belgium, 1200
- UCL Saint-Luc
-
-
Waals-Brabant
-
Ottignies-Louvain-la-Neuve, Waals-Brabant, Belgium, 1340
- Clinique Saint-Pierre Ottignies
-
-
West-Vlaanderen
-
Brugge, West-Vlaanderen, Belgium, 8000
- AZ Sint-Jan Brugge
-
Roeselare, West-Vlaanderen, Belgium, 8800
- AZ Delta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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:
- Younger than 18 years old
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LBBAP
|
Left bundle branch area pacing using conventional stylet driven pacemaker leads for cardiac resynchronization therapy
|
|
Active Comparator: BiV
|
Cardiac resynchronization therapy (CRT) using biventricular pacing (BiV)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement of procedural characteristics: Operative and fluoroscopic times
Time Frame: 1 day
|
Improvement of procedural characteristics: Operative and fluoroscopic times
|
1 day
|
|
Correction of electrical desynchrony post-implant
Time Frame: 1/6/12 months
|
Correction of electrical desynchrony post-implant, at 1/6/12 months
|
1/6/12 months
|
|
Clinical functional response (6MWT)
Time Frame: 6 months
|
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
Time Frame: 6/12 months
|
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
Time Frame: 6/12 months
|
ICD therapies at 6 and 12 months
|
6/12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean-Benoît le Polain de Waroux, MD, PhD, AZ Sint Jan Brugge AV
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LeCaRT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.