His Bundle Pacing Versus Right Ventricular Pacing

Pacing-Induced Cardiomyopathy Clinical Trial

— His-PACE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04672408
• Other study ID #: CER_GVA_2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2021
• Est. completion date: June 2023

Study information

• Verified date: December 2020
• Source: University Hospital, Geneva
• Contact: Haran Burri, MD
• Phone: +41223727200
• Email: haran.burri[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Pacing-Induced Cardiomyopathy

Intervention

Device:
• His bundle pacing
Pacing with capture of the His bundle
• Right ventricular pacing
Pacing from the right ventricular lead (septal or apical)

Locations

Country	Name	City	State
Switzerland	University Hospital Geneva	Geneva	GE

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Geneva	Carine Stettler, Elise Bakelants, Rene NKoulou

Country where clinical trial is conducted

Switzerland, 

Outcome

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