Actively Recruiting
Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction
Led by srdpiers · Updated on 2024-10-01
34
Participants Needed
2
Research Sites
211 weeks
Total Duration
On this page
Sponsors
S
srdpiers
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older with permanent atrial fibrillation and left ventricular ejection fraction less than 50% who require ventricular pacing due to bradycardia, AV junction ablation, or cardiac resynchronization therapy
- Expected ventricular pacing percentage greater than 40%
- At least 3 months of optimized heart failure medication
- Patients who already have a device but need an upgrade to a cardiac resynchronization therapy device can participate
You will not qualify if you...
- Age less than 18 years
- Pregnancy or actively wishing to become pregnant
- Not eligible for implantation of right ventricular, left bundle branch area, or left ventricular leads
- Recent valve surgery or acute heart attack within the past 6 months
- New York Heart Association functional class IV heart failure, left ventricular assist device, or heart transplant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Aarhus University Hospital
Aarhus N, Aarhus N, Denmark, DK-8200
Not Yet Recruiting
2
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2300 RC
Actively Recruiting
Research Team
S
Sebastiaan RD Piers, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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