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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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

Other trials in Belgium

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 groups in NCT05365568
Study groupRoleWhat they receive
LBBAPExperimentalNot described
Receives: Procedure: Left Bundle Branch Area Pacing (LBBAP)
BiVActive comparatorNot described
Receives: Procedure: Biventricular pacing (BiV)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  1. Improvement of procedural characteristics: Operative and fluoroscopic times

    Improvement of procedural characteristics: Operative and fluoroscopic times

    Measured: 1 day

  2. Correction of electrical desynchrony post-implant

    Correction of electrical desynchrony post-implant, at 1/6/12 months

    Measured: 1/6/12 months

  3. 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

  4. 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

  5. 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.

  1. First posted9 May 2022
  2. Study start1 Sep 2022
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT05365568.

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.

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