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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Denmark
Aarhus University Hospital
NOT_YET_RECRUITING
Aarhus N
Netherlands
Leiden University Medical Center
RECRUITING
Leiden
Contact Information
Primary
Sebastiaan RD Piers, MD, PhD
s.r.d.piers@lumc.nl
+31715262020
Time Frame
Start Date: 2024-09-10
Estimated Completion Date: 2028-10
Participants
Target number of participants: 34
Treatments
Experimental: Left bundle branch area pacing
6 months of left bundle branch area pacing.
Active_comparator: Biventricular pacing
6 months of biventricular pacing using a RV apex lead and LV lead in the coronary sinus.
Sponsors
Leads: srdpiers
Collaborators: Aarhus University Hospital

This content was sourced from clinicaltrials.gov