Actively Recruiting
LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy: the LEAP-CAR Prospective, Randomized Trial
Led by Azienda Ospedaliero Universitaria Maggiore della Carita · Updated on 2024-01-30
130
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates the potential benefit of left bundle branch area pacing (LBBAP) compared to conventional right ventricular pacing (RVP) in preventing pacing-induced cardiomyopathy (PICM) in patients with advanced atrioventricular block (second or third degree) and a baseline left ventricular ejection fraction (LVEF) greater than 45%. The study is a randomized, prospective, double-blind clinical trial designed to assess whether LBBAP can better preserve heart function compared to traditional pacing in this patient group. Participants will be randomly assigned to receive either LBBAP or conventional RVP. The pacemaker ventricular lead will be implanted in the left bundle branch area for the LBBAP group or in a conventional pacing site such as the apex or para-apical interventricular septum for the RVP group. Device choice and lead type will follow current clinical practice, with programming adjusted based on heart rhythm status. Follow-up visits will occur at 3 and 12 months, including tests and assessments to monitor heart function and quality of life. Throughout the study, patients will undergo baseline and follow-up evaluations including ECG, echocardiography, a 6-minute walk test, and quality-of-life questionnaires. Echocardiographic data will be analyzed by specialists blinded to treatment. The primary outcome is the difference in LVEF at 12 months between the two groups. Secondary outcomes include procedure success rates, changes in physical capacity, quality of life scores, and valve function. Extended follow-up up to two years will monitor heart failure events and mortality, though this is optional.
CONDITIONS
Brief Title
LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Advanced atrioventricular block (frequent 2nd or 3rd degree AV block, or atrial fibrillation with advanced AV block)
- Left ventricular ejection fraction (LVEF) above 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
- Valvular disease greater than moderate
- Previous heart transplant
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate recovery period
Participants receive a pacemaker implant with the ventricular lead placed either in the left bundle branch area or a conventional right ventricular site according to randomization.
1 implantation visit (in-person)
Duration - 12 months
Participants are monitored with device checks, ECG, and assessments of heart function and symptoms to evaluate pacing effects and safety.
Visits at 3 months and 12 months (in-person)
Duration - Up to 2 additional years (optional)
Extended observation for development of symptomatic heart failure or mortality beyond the initial 12 months.
Visits as needed depending on clinical care
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
C
Chiara Ghiglieno, MD
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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