His Bundle Pacing Versus Right Ventricular Pacing

Not Applicable

Terminated

• Conditions: Pacing-Induced Cardiomyopathy
• Interventions: Device: His bundle pacing; Device: Right ventricular pacing

• Registration Number: NCT04672408
• Lead Sponsor: University Hospital, Geneva

Brief 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.

Study Timeline

• Study First Submitted: 2020-11-28
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-17
• Study Start: 2021-08-01
• Status Verified: 2025-04
• Primary Completion: 2025-04-04
• Study Completion: 2025-04-04
• Last Update Submitted: 2025-04-06
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
His bundle pacing	His bundle pacing	Pacing programmed from the His bundle lead
Right ventricular pacing	Right ventricular pacing	Pacing programmed from the right ventricular lead

Primary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction	6 months	Assessed by gated Equilibrium Radionuclide Angiography

Secondary Outcome Measures

Name	Time	Method
Hospital admission for cardiovascular causes	up to 6 months	Duration in days of admissions for cardiovascular causes
Left ventricular peak filling rate (EDV/s)	6 months	Assessed by gated Equilibrium Radionuclide Angiography
NYHA functional class	6 months	Investigator evaluation
6-minute walk test	6 months	Investigator evaluation
Quality of life measure by SF-36 questionnaire	6 months	SF-36 questionnaire; 0-100 score (the higher the score, the better the quality of life)
Right ventricular ejection fraction	6 months	Assessed by gated Equilibrium Radionuclide Angiography

Trial Locations

Locations (1)

University Hospital Geneva; 🇨🇭 Geneva, GE, Switzerland