Clinical Trials Logo

Clinical Trial Summary

Rationale: Permanent cardiac pacing is the only available therapy in patients with atrioventricular (AV) conduction disorders and can be life-saving. Right ventricular pacing (RVP), the routine clinical practice for decades in these patients, is non-physiologic, leads to dyssynchronous electrical and mechanical activation of the ventricles, and may cause pacing-induced cardiomyopathy and heart failure. Left ventricular septal pacing (LVSP) is an emerging form of physiologic pacing that can possibly overcome the adverse effects of RVP. Study design and hypotheses: The LEAP trial is a multi-center investigator-initiated, prospective, randomized controlled, open label, blinded endpoint evaluation (PROBE) study that compares LVSP with conventional RVP. A total of four hundred seventy patients with a class I or IIa indication for pacemaker implantation due to AV conduction disorders and an expected ventricular pacing percentage >20% will be randomized 1:1 to LVSP or RVP. The primary endpoint is a composite endpoint of all-cause mortality, hospitalization for heart failure and a more than 10% decrease in left ventricular ejection fraction (LVEF) in absolute terms leading to a LVEF below 50% at one year follow-up. LVSP is anticipated to result in improved outcomes. Secondary objectives are to evaluate whether LVSP is cost-effective and associated with an improved quality of life (QOL) as compared to RVP. Quality of life is expected to improve with LVSP and reduced healthcare resource utilizations are expected to ensure lower costs in the LVSP group during follow-up, despite initial higher costs of the implantation. Study design: Multi-center investigator-initiated, prospective, randomized controlled, open label, blinded endpoint evaluation (PROBE) study. Study population: Adult patients with a bradycardia-pacing indication because of AV conduction disorders with an expected ventricular pacing percentage of ≥ 20% and a left ventricular ejection fraction (LVEF) >/= 40%. Four hundred seventy patients will be randomized 1:1 to LVSP or RVP. Intervention: LVSP vs RVP. Main study parameters/endpoints: The primary endpoint is a composite of all-cause mortality, hospitalization for heart failure, and a more than 10% point decrease in left ventricular ejection fraction (LVEF) leading to an LVEF below 50%, which as a binary combined endpoint will be determined at one year follow-up. Secondary endpoints are: - Time to first occurrence of all cause mortality or hospitalization for heart failure. - Time to first occurrence of all cause mortality. - Time to first occurrence of hospitalization for heart failure. - Time to first occurrence of atrial fibrillation (AF) de novo. - The echocardiographic changes in LVEF at one year. - The echocardiographic changes in diastolic (dys-)function at one year. - The occurrence of pacemaker related complications. - Quality of life (QOL), cost-effectiveness analyses (CEA) and budget impact analysis (BIA). The secondary endpoints (other than echocardiographic LVEF change) will be determined at the end of the follow-up period, when the last included patient has reached one year follow-up. The individual follow-up time for patients at this time point will vary with a minimum of one year.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04595487
Study type Interventional
Source Maastricht University
Contact Justin Luermans, MD PhD
Phone +31433875093
Email justin.luermans@mumc.nl
Status Recruiting
Phase N/A
Start date May 1, 2021
Completion date May 1, 2025

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Completed NCT01019213 - Acute and Chronic Effect of His-pacing in Consecutive Patients With AV-block Phase 4
Completed NCT04884100 - enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening N/A
Recruiting NCT05774262 - Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block N/A
Terminated NCT04093414 - Left Bundle Area Versus Selective His Bundle Pacing N/A
Withdrawn NCT00559143 - Biventricular Alternative Pacing Phase 4
Recruiting NCT04730921 - Impact of Left Bundle Branch Area Pacing vs. Right Ventricular Pacing in Atrioventricular Block (LEAP-Block) N/A
Recruiting NCT05585411 - PReventive Effect Of Left Bundle Branch Area Pacing Versus righT vEntricular paCing on All Cause deaTh, Heart Failure Progression, and Ventricular dysSYNChrony in Patients With Substantial Ventricular Pacing (PROTECT-SYNC): Multicenter Prospective Randomized Controlled Trial N/A
Recruiting NCT05575557 - Pulmonary Artery Pressure and Right Heart Evaluation for Patients Requiring Physiological Pacing Treatment N/A
Completed NCT00187278 - Biopace Study: Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization N/A
Completed NCT04269733 - Risk of Pacing-induced Cardiomyopathy
Recruiting NCT03851315 - Left Bundle Branch Area Pacing in AVB Patients
Completed NCT01922518 - Impact of Right Ventricular Pacing Determined by Electrocardiography N/A
Completed NCT02282033 - Safety and Performance Study of the Moderato System N/A
Recruiting NCT04624763 - Protection of Cardiac Function With Left Bundle Branch Pacing in Patients With Atrioventricular Block N/A
Completed NCT03231826 - Arrhythmias in Post-Myocardial Infarction Patients
Not yet recruiting NCT04437901 - COVIDAR - Arrhythmias in COVID-19
Recruiting NCT01717469 - Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias Phase 4
Completed NCT02154750 - AV Delay Optimization vs. Intrinsic Conduction in Pacemaker Patients With Long PR Intervals N/A
Completed NCT02462941 - Analysis of Adenosine on Sinus and Atrioventricular Nodal Conduction in the Pediatric Transplanted Heart Phase 1