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LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy

NCT05910866 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2024-01-30

No results posted yet for this study

Summary

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

  • Bradycardia
  • Heart Failure
  • Pacemaker-Induced Cardiomyopathy
  • Conduction Block, Atrioventricular
  • Cardiac Remodeling, Ventricular

Interventions

DEVICE

Left bundle branch area pacing (LBBAP)

Pacing of the conduction system of the heart to obtain physiological activation

DEVICE

Right ventricular pacing (RVP)

Conventional ventricular pacing

Sponsors & Collaborators

  • Azienda Ospedaliero Universitaria Maggiore della Carita

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-10
Primary Completion
2025-06-10
Completion
2026-06-10
FDA Device
Yes

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05910866 on ClinicalTrials.gov