RecruitingNot ApplicableNCT06620705

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

Sponsor

srdpiers

Enrollment

34 participants

Start Date

Sep 10, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure Block, Heart Pacing-Induced Cardiomyopathy

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria6

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