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

Primary Purpose

Pacing-Induced Cardiomyopathy

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
His bundle pacing
Right ventricular pacing
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pacing-Induced Cardiomyopathy focused on measuring His bundle pacing, Right ventricular pacing, Left ventricular systolic function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Geneva

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

His bundle pacing

Right ventricular pacing

Arm Description

Pacing programmed from the His bundle lead

Pacing programmed from the right ventricular lead

Outcomes

Primary Outcome Measures

Left ventricular ejection fraction
Assessed by gated Equilibrium Radionuclide Angiography

Secondary Outcome Measures

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

Full Information

First Posted
November 28, 2020
Last Updated
December 16, 2020
Sponsor
University Hospital, Geneva
Collaborators
Elise Bakelants, Carine Stettler, Rene NKoulou
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1. Study Identification

Unique Protocol Identification Number
NCT04672408
Brief Title
His Bundle Pacing Versus Right Ventricular Pacing
Acronym
His-PACE
Official Title
His Bundle Pacing Versus Right Ventricular Pacing: a Randomized Crossover Study (His-PACE)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2021 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
Collaborators
Elise Bakelants, Carine Stettler, Rene NKoulou

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pacing-Induced Cardiomyopathy
Keywords
His bundle pacing, Right ventricular pacing, Left ventricular systolic function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized crossover double-blind
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
His bundle pacing
Arm Type
Active Comparator
Arm Description
Pacing programmed from the His bundle lead
Arm Title
Right ventricular pacing
Arm Type
Placebo Comparator
Arm Description
Pacing programmed from the right ventricular lead
Intervention Type
Device
Intervention Name(s)
His bundle pacing
Intervention Description
Pacing with capture of the His bundle
Intervention Type
Device
Intervention Name(s)
Right ventricular pacing
Intervention Description
Pacing from the right ventricular lead (septal or apical)
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction
Description
Assessed by gated Equilibrium Radionuclide Angiography
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Left ventricular peak filling rate (EDV/s)
Description
Assessed by gated Equilibrium Radionuclide Angiography
Time Frame
6 months
Title
NYHA functional class
Description
Investigator evaluation
Time Frame
6 months
Title
6-minute walk test
Description
Investigator evaluation
Time Frame
6 months
Title
Quality of life measure by SF-36 questionnaire
Description
SF-36 questionnaire; 0-100 score (the higher the score, the better the quality of life)
Time Frame
6 months
Title
Right ventricular ejection fraction
Description
Assessed by gated Equilibrium Radionuclide Angiography
Time Frame
6 months
Title
Hospital admission for cardiovascular causes
Description
Number of days of admissions for cardiovascular causes
Time Frame
6 months
Title
Hospital admission for cardiovascular causes
Description
Duration in days of admissions for cardiovascular causes
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haran Burri, MD
Phone
+41223727200
Email
haran.burri@hcuge.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haran Burri, MD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Geneva
City
Geneva
State/Province
GE
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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)

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His Bundle Pacing Versus Right Ventricular Pacing

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