Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGINTERVENTIONAL

Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction

Pacing Away from Heart Failure: Left Bundle Branch Area Pacing or Biventricular Pacing in Patients with Atrial Fibrillation and Left Ventricular Dysfunction

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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

Locations (2)

Aarhus University Hospital
Aarhus N, Aarhus N, Denmark
Leiden University Medical Center
Leiden, South Holland, Netherlands