An interventional study of Left bundle branch area pacing and Biventricular pacing in Heart Failure, Block, Heart and Pacing-Induced Cardiomyopathy, sponsored by srdpiers. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by srdpiers · Not applicable, Interventional, and Treatment
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.
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:
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).
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 34 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →This is the only study on the registry with srdpiers as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
6 months of left bundle branch area pacing.
Device: Left bundle branch area pacing
6 months of biventricular pacing using a RV apex lead and LV lead in the coronary sinus.
Device: Biventricular pacing
Pacing of the left bundle branch area using a transvenous pacemaker lead
Also known as: Conduction system pacing, Cardiac resynchronization therapy
Pacing of the right and left ventricle using transvenous pacemaker leads
Also known as: Cardiac resynchronization therapy
Left ventricular end-systolic volume (LVESV) change
Left ventricular end-systolic volume change measured by echocardiography
Time frame: 6 months
Change in New York Heart Association functional class
Change in New York Heart Association functional class (NYHA)
Time frame: 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).
Time frame: 6 months
Change in 6-minute walking distance
Change in 6-minute walking distance
Time frame: 6 months
Change in QRS duration
Change in QRS duration on the 12-lead ECG
Time frame: 6 months
Change in vectorcardiographic QRS area
Change in vectorcardiographic QRS area on the vectorcardiogram reconstructed from a regular 12-lead ECG
Time frame: 6 months
Change in left ventricular function
Change in left ventricular function ejection fraction and global longitudinal strain on echocardiography
Time frame: 6 months
Change in NT-proBNP
Change in NT-proBNP as a heart failure biomarker
Time frame: 6 months
Complications
Complications related to device and leads
Time frame: 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.
Time frame: 6 months
Costs
Costs related to the device and leads
Time frame: 6 months
Plan to share: Yes — The data will be shared with other researchers whenever reasonable and of potential benefit for patients.
Supporting information: Study protocol, Clinical study report
Time frame: After completion of the study and publication, the data will be shared with other researchers whenever reasonable and of potential benefit for patients.
Access criteria: Whenever reasonable and of potential benefit for patients.
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Sep 2027, 36 months after the start.
Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 36 months is above that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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