Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction
- Conditions
- Heart FailureBlock, HeartPacing-Induced Cardiomyopathy
- Interventions
- Device: Left bundle branch area pacingDevice: Biventricular pacing
- Registration Number
- NCT06620705
- Lead Sponsor
- srdpiers
- Brief 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. 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 34
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Left bundle branch area pacing Left bundle branch area pacing 6 months of left bundle branch area pacing. Biventricular pacing Biventricular pacing 6 months of biventricular pacing using a RV apex lead and LV lead in the coronary sinus.
- Primary Outcome Measures
Name Time Method Left ventricular end-systolic volume (LVESV) change 6 months Left ventricular end-systolic volume change measured by echocardiography
- Secondary Outcome Measures
Name Time Method Change in New York Heart Association functional class 6 months Change in New York Heart Association functional class (NYHA)
Change in Minnesota living with heart failure questionnaire 6 months 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).
Change in 6-minute walking distance 6 months Change in 6-minute walking distance
Change in QRS duration 6 months Change in QRS duration on the 12-lead ECG
Change in vectorcardiographic QRS area 6 months Change in vectorcardiographic QRS area on the vectorcardiogram reconstructed from a regular 12-lead ECG
Change in left ventricular function 6 months Change in left ventricular function ejection fraction and global longitudinal strain on echocardiography
Change in NT-proBNP 6 months Change in NT-proBNP as a heart failure biomarker
Complications 6 months Complications related to device and leads
Lead pacing thresholds 6 months Lead pacing thresholds, expressed as volts at pulse width (e.g. 0.4 V @ 0.4 ms). A lower pacing threshold is better.
Costs 6 months Costs related to the device and leads
Trial Locations
- Locations (2)
Aarhus University Hospital
🇩🇰Aarhus N, Denmark
Leiden University Medical Center
🇳🇱Leiden, Zuid-Holland, Netherlands