Permanent left ventricular septal pacing versus right ventricular pacing in patients with atrioventricular conduction disorders: a randomized trial: LEAP trial

Recruiting

Conditions: Cardiac PacingPacing-Induced CardiomyopathyConduction System PacingLeft Ventricular Septal PacingAtrioventricular Block

Registration Number: NL-OMON28779

Lead Sponsor: Maastricht University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 470

Inclusion Criteria

•Age > 18y
•Life expectancy with good functional status of > 1y
•Class I or IIa pacemaker indication due to an atrioventricular conduction disorder
oAcquired 3rd or 2nd degree AVB
oAtrial arrhythmia with slow ventricular conduction
•Expected ventricular pacing percentage > 20%
•LVEF >35%
•Signed and dated informed consent form

Exclusion Criteria

•Heart failure NYHA class III-IV
•Class I indication for CRT
•Class I indication for ICD
•Previous implanted CIED (except for ILR)
•Atrial arrhythmia with planned AV junction ablation
•PCI or CABG <30 days before enrollment
•Valvular heart disease with indication for valve repair or replacement
•Hypertrophic cardiomyopathy with interventricular septal thickness > 2 cm
•Renal insufficiency requiring hemodialysis
•Active infectious disease or malignancy
•Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is a composite 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%, which as a binary combined endpoint will be determined at one year follow-up.

Secondary Outcome Measures

Name	Time	Method
-Time to first occurrence of all cause mortality or hospitalization for heart failure.<br>-Time to first occurrence of all cause mortality.<br>-Time to first occurrence of hospitalization for heart failure. <br>-Time to first occurrence of atrial fibrillation (AF) de novo. <br>-The echocardiographic changes in LVEF at one year.<br>-The echocardiographic changes in diastolic (dys-)function at one year.<br>-The occurrence of pacemaker related complications. <br>- Quality of life (QOL), cost-effectiveness analyses (CEA) and budget impact analysis (BIA).<br>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.