LVSP vs RVP in Patients With AV Conduction Disorders

Launched by MAASTRICHT UNIVERSITY · Oct 19, 2020

Keywords

ClinConnect Summary

The LEAP trial is studying two different methods of cardiac pacing for patients with atrioventricular (AV) conduction disorders, which are conditions that affect how electrical signals move through the heart. The trial compares traditional right ventricular pacing (RVP) with a newer approach called left ventricular septal pacing (LVSP). RVP has been the standard treatment, but it can lead to complications like heart failure. LVSP is thought to be a better option because it may help the heart work more naturally and reduce these risks. The goal of the study is to see if LVSP leads to better health outcomes, such as fewer hospital visits and improved heart function, over the course of a year.

To be eligible for this trial, participants need to be adults over 18 years old who are recommended for a pacemaker because of their AV conduction disorder. They should expect to have their heart pace more than 20% of the time and have a left ventricular ejection fraction (a measure of heart function) of at least 40%. The study will involve around 470 patients who will be randomly assigned to receive either LVSP or RVP. Participants can anticipate regular check-ups and assessments throughout the year to monitor their heart health and quality of life. It’s important to know that the trial is currently recruiting, and those interested should discuss participation with their healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \> 18y
• • Life expectancy with good functional status of \> 1y
• • Class I or IIa pacemaker indication due to AV conduction disorder
• • Acquired 3rd or 2nd degree AVB
• • Atrial arrhythmia with slow ventricular conduction
• • Expected ventricular pacing percentage \> 20%
• • LVEF \>/= 40%
• • Signed and dated informed consent form
• Exclusion Criteria:
• • HF 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 septum thickness \> 2 cm
• • Renal insufficiency requiring hemodialysis
• • Active infectious disease or malignancy
• • Pregnancy