His Bundle Pacing Versus Right Ventricular Pacing (His-PACE)

University Hospitals (UH)

Status: Terminated

Conditions: Pacing-Induced Cardiomyopathy

Treatments: Device: His bundle pacing; Device: Right ventricular pacing

Study type: Interventional

Funder types: Other

Identifiers

NCT04672408

CER_GVA_2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Baseline LVEF>40%
• Standard pacing indication with >20% VP
• Functional His bundle lead with confirmed His capture
• Functional right ventricular lead with myocardial capture

Exclusion criteria

• Unable to sign an informed consent form

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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29 participants in 2 patient groups, including a placebo group

His bundle pacing

Active Comparator group

Description:

Pacing programmed from the His bundle lead

Treatment:

Device: His bundle pacing

Right ventricular pacing

Placebo Comparator group

Description:

Pacing programmed from the right ventricular lead

Treatment:

Device: Right ventricular pacing