Actively Recruiting
LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy
Led by Azienda Ospedaliero Universitaria Maggiore della Carita · Updated on 2024-01-30
130
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
LEAP-CAR will evaluate the benefit of left bundle branch area pacing (LBBAP), comparing to conventional right ventricular pacing (RVP), in preventing pacing-induced cardiomyopathy (PICM) in patients undergoing pacemaker implant for advanced (2° or 3° degree) atrioventricular block, with baseline left ventricular ejection fraction (LVEF) \>45%. LEAP-CAR is a randomized, prospective, double blind clinical trial.
CONDITIONS
Official Title
LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Advanced second or third degree atrioventricular block or atrial fibrillation with advanced AV block
- Left ventricular ejection fraction (LVEF) greater than 45%
You will not qualify if you...
- Left ventricular ejection fraction (LVEF) 45% or less
- Signs or symptoms of heart failure at enrollment
- Unstable angina or acute coronary syndrome within 3 months
- Percutaneous coronary intervention or coronary-artery bypass surgery within 3 months
- Life expectancy less than 6 months
- Previous hospitalization for heart failure
- Evidence of pulmonary artery hypertension of any origin
- Valvular disease greater than moderate
- Previous heart transplant
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital "Maggiore della Carità", Division of Cardiology
Novara, Italy, 28100
Actively Recruiting
Research Team
G
Gabriele Dell'Era, MD
CONTACT
C
Chiara Ghiglieno, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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