Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Left bundle branch area pacing, Biventricular pacing.
- Who it may be relevant to
- Registry conditions: Heart Failure, Block, Heart, Pacing-Induced Cardiomyopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark, Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pacing Away from Heart Failure: Left Bundle Branch Area Pacing or Biventricular Pacing in Patients with Atrial Fibrillation and Left Ventricular Dysfunction
Overview
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:
1. To compare LVESV change between LBBAP and biventricular pacing in patients with AF and LV dysfunction.
Secondary objectives: 2. 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).
Interventions
- Device Left bundle branch area pacing
Pacing of the left bundle branch area using a transvenous pacemaker lead - Device Biventricular pacing
Pacing of the right and left ventricle using transvenous pacemaker leads
Primary outcome measures
- Left ventricular end-systolic volume (LVESV) change [Time frame: 6 months]
Secondary outcome measures (10)
- 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]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Aarhus University Hospital — Aarhus N
Netherlands · 1 center
- Leiden University Medical Center — Leiden
Identifiers
NCT: NCT06620705 · NL84372.058.23