Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction
Recruiting · NCT06620705 · Interventional (participants receive a specific treatment) · Lead sponsor: srdpiers
View the official record on ClinicalTrials.gov →Interventions studied
Biventricular pacingLeft bundle branch area pacing
What this trial is about
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 can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
- f 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
Where it is running
4 locations listed.
- Aarhus University Hospital - Aarhus N, Aarhus N, Denmark
- Aarhus University Hospital - Aarhus N, Aarhus N, Denmark
- Leiden University Medical Center - Leiden, South Holland, Netherlands
- Leiden University Medical Center - Leiden, South Holland, Netherlands