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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pacing-Induced Cardiomyopathy
• Intervention / Treatment: Device: His bundle pacing; Device: Right ventricular pacing

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haran Burri, MD; Phone Number: +41223727200; Email: haran.burri@hcuge.ch

Study Locations

• Switzerland
  • GE
    • Geneva, GE, Switzerland, 1211
      • University Hospital Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: His bundle pacing; Pacing programmed from the His bundle lead	Device: His bundle pacing; Pacing with capture of the His bundle
Placebo Comparator: Right ventricular pacing; Pacing programmed from the right ventricular lead	Device: Right ventricular pacing; Pacing from the right ventricular lead (septal or apical)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular ejection fraction	Assessed by gated Equilibrium Radionuclide Angiography	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular peak filling rate (EDV/s)	Assessed by gated Equilibrium Radionuclide Angiography	6 months
NYHA functional class	Investigator evaluation	6 months
6-minute walk test	Investigator evaluation	6 months
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
Right ventricular ejection fraction	Assessed by gated Equilibrium Radionuclide Angiography	6 months
Hospital admission for cardiovascular causes	Number of days of admissions for cardiovascular causes	6 months
Hospital admission for cardiovascular causes	Duration in days of admissions for cardiovascular causes	up to 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: Elise Bakelants; Carine Stettler; Rene NKoulou
• Investigators: Principal Investigator: Haran Burri, MD, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: November 28, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: His bundle pacing; Right ventricular pacing; Left ventricular systolic function
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: CER_GVA_2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Yareta data repository
• IPD Sharing Time Frame: At the ocmpletion of the study
• IPD Sharing Access Criteria: Open access for at least 15 years (as per Swiss law)
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No