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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28779

Enrollment

470

Registered

2021-08-17

Start date

2021-05-01

Completion date

Unknown

Last updated

2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Pacing Pacing-Induced Cardiomyopathy Conduction System Pacing Left Ventricular Septal Pacing Atrioventricular Block

Interventions

Experimental intervention: Left ventricular septal pacing Implantation of a pacemaker with the ventricular lead delivered transvenously through the interventricular septum (IVS) to the left ventricul

Eligibility

Inclusion criteria

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

Exclusion criteria

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 2 cm • Renal insufficiency requiring hemodialysis • Active infectious disease or malignancy • Pregnancy

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- 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.	—

Measure

Time frame

- 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.

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Contacts

Public ContactJustin Luermans

Maastricht University

justin.luermans@mumc.nl+31433875093

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)