NCT04672408

His Bundle Pacing Versus Right Ventricular Pacing

His Bundle Pacing Versus Right Ventricular Pacing: a Randomized Crossover Study (His-PACE)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will randomize cross-over periods of 6 months of right ventricular pacing and His bundle pacing in patients with baseline left ventricular ejection fraction (LVEF)\>40%. The primary outcome measure is LVEF.

Detailed description

Monocentric, randomized, double-blind comparative crossover clinical study. Patients with a standard pacing indication with \>20% ventricular pacing, with a baseline LVEF \>40%, implanted with a functioning His bundle lead and a backup right ventricular lead, will be randomized to 6-months periods of right ventricular pacing and of His bundle pacing. The primary outcome is LVEF assessed by gated Equilibrium Radionuclide Angiography. Secondary outcomes are diastolic function, New York Heart Association (NYHA) functional class, quality of life, 6-minute walk test, heart failure hospitalisations and device electrical parameters.

Conditions

• Pacing-Induced Cardiomyopathy

Interventions

Type	Name	Description
DEVICE	His bundle pacing	Pacing with capture of the His bundle
DEVICE	Right ventricular pacing	Pacing from the right ventricular lead (septal or apical)

Timeline

• Start date: 2021-08-01
• Primary completion: 2025-04-04
• Completion: 2025-04-04
• First posted: 2020-12-17
• Last updated: 2025-04-09

Locations

1 site across 1 country: Switzerland