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

April 6, 2025 updated by: Haran Burri, MD, University Hospital, Geneva

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

Terminated

Conditions

Intervention / Treatment

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 (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 6 months
Assessed by gated Equilibrium Radionuclide Angiography
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Collaborators

Elise Bakelants
Carine Stettler
Rene NKoulou

Investigators

  • Principal Investigator: Haran Burri, MD, University Hospital, Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

April 4, 2025

Study Completion (Actual)

April 4, 2025

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)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 6, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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
  • SAP
  • 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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