Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05910866

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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%
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Hospital "Maggiore della Carità", Division of Cardiology

Novara, Italy, 28100

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here