Heart Failure with Reduced Ejection FractionLeCaRTNCT05365568
Left Bundle Branch Area Pacing Using Conventional Stylet-driven Pacemaker Leads for Cardiac Resynchronization Therapy
A study testing Left Bundle Branch Area Pacing (LBBAP) and Biventricular pacing (BiV) in people with Heart Failure with Reduced Ejection Fraction, run by AZ Sint-Jan AV at 11 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure with Reduced Ejection Fraction
- What is being tested?
- Left Bundle Branch Area Pacing (LBBAP) and Biventricular pacing (BiV)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 11 sitesBelgium
- Study dates
- 1 Sep 2022to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Belgium11 sites
AZ Sint-Jan Brugge
Bruges, West-Vlaanderen, 8000
UZA
Edegem, Antwerpen, 2650
UZ Gent
Ghent, Oost-Vlaanderen, 9000
CHU HELORA - Site Jolimont
Haine-Saint-Paul, 7100
Jessa Ziekenhuis Hasselt
Hasselt, Limburg, 3500
UZ Leuven
Leuven, Vlaams-Brabant, 3000
CHR Citadelle Liège
Liège, Liège, 4000
CHU Charleroi
Lodelinsart, Henegouwen, 6042
Clinique Saint-Pierre Ottignies
Ottignies-Louvain-la-Neuve, Waals-Brabant, 1340
AZ Delta
Roeselare, West-Vlaanderen, 8800
UCL Saint-Luc
Woluwe-Saint-Lambert, Vlaams-Brabant, 1200
About this study
Official title: Left Bundle Branch Area Pacing Using Conventional Stylet Driven Pacemaker Leads for Cardiac Resynchronization Therapy: a Randomized Study
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.
Read the 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.
- Being tested
- Left Bundle Branch Area Pacing (LBBAP), Biventricular pacing (BiV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Bundle Branch Area Pacing (LBBAP)Procedure or surgery
Left bundle branch area pacing using conventional stylet driven pacemaker leads for cardiac resynchronization therapy
Biventricular pacing (BiV)Procedure or surgery
Cardiac resynchronization therapy (CRT) using biventricular pacing (BiV)
| Study group | Role | What they receive |
|---|---|---|
| LBBAP | Experimental | Not described Receives: Procedure: Left Bundle Branch Area Pacing (LBBAP) |
| BiV | Active comparator | Not described Receives: Procedure: Biventricular pacing (BiV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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…)
Measured: 12 months
Secondary outcomes (5)
Improvement of procedural characteristics: Operative and fluoroscopic times
Improvement of procedural characteristics: Operative and fluoroscopic times
Measured: 1 day
Correction of electrical desynchrony post-implant
Correction of electrical desynchrony post-implant, at 1/6/12 months
Measured: 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
Measured: 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
Measured: 6/12 months
Implantable cardioverter defibrillator (ICD) therapies
ICD therapies at 6 and 12 months
Measured: 6/12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Sep 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure with Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Benoît Le Polain de Waroux, AZ Sint-Jan AV
- Investigators
- Jean-Benoît le Polain de Waroux, MD, PhD, Principal investigator, AZ Sint Jan Brugge AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365568
- Sponsor's protocol ID
- LeCaRT
- Acronym
- LeCaRT
- Status last verified
- Sep 2024
- First submitted
- 29 Apr 2022
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Bundle Branch Area Pacing Using Conventional Stylet Driven Pacemaker Leads for Cardiac Resynchronization Therapy: a Randomized Study
- ClinicalTrials.gov ID
- NCT05365568
- Acronym / sponsor ID
- LeCaRT / LeCaRT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 170 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LBBAP | Experimental | Procedure: Left Bundle Branch Area Pacing (LBBAP) |
| BiV | Active comparator | Procedure: Biventricular pacing (BiV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left Bundle Branch Area Pacing (LBBAP)Left bundle branch area pacing using conventional stylet driven pacemaker leads for cardiac resynchronization therapy | Procedure or surgery | LBBAP |
| Biventricular pacing (BiV)Cardiac resynchronization therapy (CRT) using biventricular pacing (BiV) | Procedure or surgery | BiV |
Primary outcome
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…)
5 secondary outcomes
Improvement of procedural characteristics: Operative and fluoroscopic times
Time frame: 1 day
Correction of electrical desynchrony post-implant
Time frame: 1/6/12 months
Clinical functional response (6MWT)
Time frame: 6 months
Left ventricular reverse remodelling
Time frame: 6/12 months
Implantable cardioverter defibrillator (ICD) therapies
Time frame: 6/12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Benoît le Polain de Waroux, MD, PhD principal investigator
AZ Sint Jan Brugge AV
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left Bundle Branch Area Pacing (LBBAP) and Biventricular pacing (BiV) in people with Heart Failure with Reduced Ejection Fraction, run by AZ Sint-Jan AV at 11 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024; AzTrials last refreshed its copy on 28 Oct 2026.