Heart FailureNCT06620705
Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction
A study testing Left bundle branch area pacing and Biventricular pacing in people with Heart Failure and Block, Heart, run by srdpiers at 2 sites in 2 countries.
Trial summary
It is unknown whether left bundle branch area pacing (LBBAP) or biventricular pacing best prevents or reverses left ventricular (LV) adverse remodelling in patients with atrial fibrillation (AF) who require ventricular pacing or CRT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Block, Heart, Pacing-Induced Cardiomyopathy
- What is being tested?
- Left bundle branch area pacing and Biventricular pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Sep 2024to Oct 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
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Adults ≥18 years with permanent AF and LVEF \< 50% who either require ventricular pacing because of bradycardia including patients undergoing AV junction ablation, or have an indication for cardiac resynchronization therapy.
- Expected percentage of ventricular pacing \> 40%
- ≥ 3 months of heart failure medication optimization
- Of note, patients who already have a device, but require an upgrade to a CRT device, can also be included
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Age \< 18 years
- Pregnancy or active pregnancy wish
- Not eligible for implantation of an RV lead, LBBAP lead, or LV lead in the coronary sinus
- Recent valve intervention/surgery or acute myocardial infarction (\< 6 months)
- NYHA functional class IV heart failure, left ventricular assist device or cardiac transplant
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Denmark1 site, 1 recruiting
- Not yet recruiting
Aarhus University Hospital
Aarhus N, Aarhus N, DK-8200
Jens Kristensen, MD, PhD, +45 7845 0000, jens.kristensen@auh.rm.dk
Mads B Kronborg, MD, PhD
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 2300 RC
Sebastiaan RD Piers, MD, PhD, 0031715262020, s.r.d.piers@lumc.nl
Sebastiaan RD Piers, MD, PhD
About this study
Official title: Pacing Away from Heart Failure: Left Bundle Branch Area Pacing or Biventricular Pacing in Patients with Atrial Fibrillation and Left Ventricular Dysfunction
It is unknown whether left bundle branch area pacing (LBBAP) or biventricular pacing best prevents or reverses left ventricular (LV) adverse remodelling in patients with atrial fibrillation (AF) who require ventricular pacing or CRT. This randomized non-inferiority cross-over trial will compare left ventricular end-systolic volume change and secondary endpoints between LBBAP and biventricular pacing in patients with AF and LV dysfunction.
Read the detailed description
Rationale: Patients with atrial fibrillation (AF) and left ventricular (LV) dysfunction may require ventricular pacing because of bradycardia, AV junction ablation, or for cardiac resynchronization therapy. Right ventricular (RV) pacing is associated with the risk of adverse LV remodelling and heart failure, in particular in those with pre-existing LV dysfunction. Both LBBAP and biventricular pacing can prevent LV dyssynchrony. It is unknown which pacing mode best prevents or reverses LV adverse remodelling in patients with AF who require ventricular pacing or CRT.
Primary objectives:
- To compare LVESV change between LBBAP and biventricular pacing in patients with AF and LV dysfunction. Secondary objectives:
- To compare change in quality of life, New York Heart Association functional class, 6-minute walking distance, QRS duration, vectorcardiographic QRS area, left ventricular ejection fraction (LVEF), global longitudinal strain and NT-proBNP between LBBAP and biventricular pacing in patients with AF and LV dysfunction.
Study design: Randomized patient and assessor blinded non-inferiority cross-over trial.
Study population: Patients with permanent AF and LVEF \< 50% who require ventricular pacing because of bradycardia, AV junction ablation, or CRT.
Intervention: Patients will be randomized according to a crossover design to first 6 months of LBBAP and then 6 months of biventricular pacing, or vice versa.
After finishing the randomization phase of the study at 12 months, patients will be followed according to routine clinical practice. Clinical follow-up, an ECG, device interrogation and echocardiography will be performed at 36 months (2 years after finishing the randomization phase) in all patients.
Main study parameters/endpoints: New York Heart Association (NYHA) functional class, Minnesota Living with Heart Failure Questionnaire (MLHFQ), 6-minute walking distance, ECG (vectorcardiographic QRS area, QRS duration), echocardiography (LVESV, LVEF, global longitudinal strain), NT-proBNP, lead and device performance (sensing, pacing, expected battery life), complications and costs will be evaluated for each pacing mode.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: For the purpose of this randomized controlled trial, patients will also receive a LBBAP lead. The additional risk of serious adverse events is ~1.5% (lead dislodgement 1.1%, 0.4% acute coronary syndrome [all managed conservatively without further sequelae in prior studies]).(1) Patients who participate in the trial will have 3 extra follow-up visits, 4 extra questionnaires, 3 extra ECGs, 3 extra device interrogations, 3 extra echocardiograms and 4 extra blood samples (5 mL each).
- Conditions
- Heart Failure, Block, Heart, Pacing-Induced Cardiomyopathy
- Being tested
- Left bundle branch area pacing, Biventricular pacing
- Keywords
- pacing, cardiac resynchronization therapy, left bundle branch area pacing, conduction system pacing, heart failure, heart block
- Medical subject headings
- Heart Failure, Heart Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left bundle branch area pacingDevice
Also called Conduction system pacing, Cardiac resynchronization therapy
Pacing of the left bundle branch area using a transvenous pacemaker lead
Biventricular pacingDevice
Also called Cardiac resynchronization therapy
Pacing of the right and left ventricle using transvenous pacemaker leads
| Study group | Role | What they receive |
|---|---|---|
| Left bundle branch area pacing | Experimental | 6 months of left bundle branch area pacing. Receives: Device: Left bundle branch area pacing |
| Biventricular pacing | Active comparator | 6 months of biventricular pacing using a RV apex lead and LV lead in the coronary sinus. Receives: Device: Biventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular end-systolic volume (LVESV) change
Left ventricular end-systolic volume change measured by echocardiography
Measured: 6 months
Secondary outcomes (10)
Change in New York Heart Association functional class
Change in New York Heart Association functional class (NYHA)
Measured: 6 months
Change in Minnesota living with heart failure questionnaire
The Minnesota living with heart failure questionnaire (MLHFQ) is a self-administered disease-specific questionnaire for patients with heart failure, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of heart failure on quality of life, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst quality of life).
Measured: 6 months
Change in 6-minute walking distance
Change in 6-minute walking distance
Measured: 6 months
Change in QRS duration
Change in QRS duration on the 12-lead ECG
Measured: 6 months
Change in vectorcardiographic QRS area
Change in vectorcardiographic QRS area on the vectorcardiogram reconstructed from a regular 12-lead ECG
Measured: 6 months
Change in left ventricular function
Change in left ventricular function ejection fraction and global longitudinal strain on echocardiography
Measured: 6 months
Change in NT-proBNP
Change in NT-proBNP as a heart failure biomarker
Measured: 6 months
Complications
Complications related to device and leads
Measured: 6 months
Lead pacing thresholds
Lead pacing thresholds, expressed as volts at pulse width (e.g. 0.4 V @ 0.4 ms). A lower pacing threshold is better.
Measured: 6 months
Costs
Costs related to the device and leads
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start10 Sep 2024
- Primary completionSep 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Crossover
- Model description
- Randomized patient and assessor blinded non-inferiority cross-over trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- srdpiers
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor-investigator, srdpiers, Leiden University Medical Center
- Investigators
- Sebastiaan Piers, MD, PhD, Principal investigator, Leiden University Medical Center, Leiden, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620705
- Sponsor's protocol ID
- NL84372.058.23
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The data will be shared with other researchers whenever reasonable and of potential benefit for patients.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pacing Away from Heart Failure: Left Bundle Branch Area Pacing or Biventricular Pacing in Patients with Atrial Fibrillation and Left Ventricular Dysfunction
- ClinicalTrials.gov ID
- NCT06620705
- Acronym / sponsor ID
- NL84372.058.23
- Conditions
- Heart Failure, Block, Heart, Pacing-Induced Cardiomyopathy
- Keywords
- pacing, cardiac resynchronization therapy, left bundle branch area pacing, conduction system pacing, heart failure, heart block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- srdpiersUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 1 Oct 2024 (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.
It is unknown whether left bundle branch area pacing (LBBAP) or biventricular pacing best prevents or reverses left ventricular (LV) adverse remodelling in patients with atrial fibrillation (AF) who require ventricular pacing or CRT. This randomized non-inferiority cross-over trial will compare left ventricular end-systolic volume change and secondary endpoints between LBBAP and biventricular pacing in patients with AF and LV dysfunction.
Detailed description
Rationale: Patients with atrial fibrillation (AF) and left ventricular (LV) dysfunction may require ventricular pacing because of bradycardia, AV junction ablation, or for cardiac resynchronization therapy. Right ventricular (RV) pacing is associated with the risk of adverse LV remodelling and heart failure, in particular in those with pre-existing LV dysfunction. Both LBBAP and biventricular pacing can prevent LV dyssynchrony. It is unknown which pacing mode best prevents or reverses LV adverse remodelling in patients with AF who require ventricular pacing or CRT.
Primary objectives:
- To compare LVESV change between LBBAP and biventricular pacing in patients with AF and LV dysfunction. Secondary objectives:
- To compare change in quality of life, New York Heart Association functional class, 6-minute walking distance, QRS duration, vectorcardiographic QRS area, left ventricular ejection fraction (LVEF), global longitudinal strain and NT-proBNP between LBBAP and biventricular pacing in patients with AF and LV dysfunction.
Study design: Randomized patient and assessor blinded non-inferiority cross-over trial.
Study population: Patients with permanent AF and LVEF \< 50% who require ventricular pacing because of bradycardia, AV junction ablation, or CRT.
Intervention: Patients will be randomized according to a crossover design to first 6 months of LBBAP and then 6 months of biventricular pacing, or vice versa.
After finishing the randomization phase of the study at 12 months, patients will be followed according to routine clinical practice. Clinical follow-up, an ECG, device interrogation and echocardiography will be performed at 36 months (2 years after finishing the randomization phase) in all patients.
Main study parameters/endpoints: New York Heart Association (NYHA) functional class, Minnesota Living with Heart Failure Questionnaire (MLHFQ), 6-minute walking distance, ECG (vectorcardiographic QRS area, QRS duration), echocardiography (LVESV, LVEF, global longitudinal strain), NT-proBNP, lead and device performance (sensing, pacing, expected battery life), complications and costs will be evaluated for each pacing mode.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: For the purpose of this randomized controlled trial, patients will also receive a LBBAP lead. The additional risk of serious adverse events is ~1.5% (lead dislodgement 1.1%, 0.4% acute coronary syndrome [all managed conservatively without further sequelae in prior studies]).(1) Patients who participate in the trial will have 3 extra follow-up visits, 4 extra questionnaires, 3 extra ECGs, 3 extra device interrogations, 3 extra echocardiograms and 4 extra blood samples (5 mL each).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized patient and assessor blinded non-inferiority cross-over trial.
| Arm | Type | Receives |
|---|---|---|
| Left bundle branch area pacing | Experimental | Device: Left bundle branch area pacing6 months of left bundle branch area pacing. |
| Biventricular pacing | Active comparator | Device: Biventricular pacing6 months of biventricular pacing using a RV apex lead and LV lead in the coronary sinus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Adults ≥18 years with permanent AF and LVEF \< 50% who either require ventricular pacing because of bradycardia including patients undergoing AV junction ablation, or have an indication for cardiac resynchronization therapy.
- Expected percentage of ventricular pacing \> 40%
- ≥ 3 months of heart failure medication optimization
- Of note, patients who already have a device, but require an upgrade to a CRT device, can also be included
Key exclusion criteria (6 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Age \< 18 years
- Pregnancy or active pregnancy wish
- Not eligible for implantation of an RV lead, LBBAP lead, or LV lead in the coronary sinus
- Recent valve intervention/surgery or acute myocardial infarction (\< 6 months)
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 pacingAlso: Conduction system pacing, Cardiac resynchronization therapyPacing of the left bundle branch area using a transvenous pacemaker lead | Device | Left bundle branch area pacing |
| Biventricular pacingAlso: Cardiac resynchronization therapyPacing of the right and left ventricle using transvenous pacemaker leads | Device | Biventricular pacing |
Primary outcome
Left ventricular end-systolic volume (LVESV) change
Time frame: 6 months
Left ventricular end-systolic volume change measured by echocardiography
10 secondary outcomes
Change in New York Heart Association functional class
Time frame: 6 months
Change in Minnesota living with heart failure questionnaire
Time frame: 6 months
Change in 6-minute walking distance
Time frame: 6 months
Change in QRS duration
Time frame: 6 months
Change in vectorcardiographic QRS area
Time frame: 6 months
Change in left ventricular function
Time frame: 6 months
Change in NT-proBNP
Time frame: 6 months
Complications
Time frame: 6 months
Lead pacing thresholds
Time frame: 6 months
Costs
Time frame: 6 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 1 Oct 2024.
- Individual participant dataSharing planned: Yes. The data will be shared with other researchers whenever reasonable and of potential benefit for patients.
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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.
Sebastiaan Piers, MD, PhD principal investigator
Leiden University Medical Center, Leiden, the Netherlands
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left bundle branch area pacing and Biventricular pacing in people with Heart Failure and Block, Heart, run by srdpiers at 2 sites in 2 countries.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Netherlands. 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?
Contact Sebastiaan RD Piers, MD, PhD (+31715262020, s.r.d.piers@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular end-systolic volume (LVESV) change (time frame: 6 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 1 Oct 2024.