Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction
NCT06620705 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2024-10-01
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.
Conditions
- Heart Failure
- Block, Heart
- Pacing-Induced Cardiomyopathy
Interventions
- 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
Sponsors & Collaborators
-
Aarhus University Hospital
collaborator OTHER -
srdpiers
lead OTHER
Principal Investigators
-
Sebastiaan Piers, MD, PhD · Leiden University Medical Center, Leiden, the Netherlands
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-10
- Primary Completion
- 2027-09-30
- Completion
- 2028-10-31
- FDA Device
- Yes
Countries
- Denmark
- Netherlands
Study Locations
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