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

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ClinicalTrials.gov Identifier: NCT04672408
Recruitment Status : Not yet recruiting
First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Collaborators:
Elise Bakelants
Carine Stettler
Rene NKoulou
Information provided by (Responsible Party):
Haran Burri, MD, 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.

Condition or disease Intervention/treatment Phase
Pacing-Induced Cardiomyopathy Device: His bundle pacing Device: Right ventricular pacing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized crossover double-blind
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: His Bundle Pacing Versus Right Ventricular Pacing: a Randomized Crossover Study (His-PACE)
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : June 2023

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)




Primary Outcome Measures :
  1. Left ventricular ejection fraction [ Time Frame: 6 months ]
    Assessed by gated Equilibrium Radionuclide Angiography


Secondary Outcome Measures :
  1. Left ventricular peak filling rate (EDV/s) [ Time Frame: 6 months ]
    Assessed by gated Equilibrium Radionuclide Angiography

  2. NYHA functional class [ Time Frame: 6 months ]
    Investigator evaluation

  3. 6-minute walk test [ Time Frame: 6 months ]
    Investigator evaluation

  4. 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)

  5. Right ventricular ejection fraction [ Time Frame: 6 months ]
    Assessed by gated Equilibrium Radionuclide Angiography

  6. Hospital admission for cardiovascular causes [ Time Frame: 6 months ]
    Number of days of admissions for cardiovascular causes

  7. Hospital admission for cardiovascular causes [ Time Frame: up to 6 months ]
    Duration in days of admissions for cardiovascular causes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04672408


Contacts
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Contact: Haran Burri, MD +41223727200 haran.burri@hcuge.ch

Locations
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Switzerland
University Hospital Geneva
Geneva, GE, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Elise Bakelants
Carine Stettler
Rene NKoulou
Investigators
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Principal Investigator: Haran Burri, MD University Hospital, Geneva
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Responsible Party: Haran Burri, MD, Professor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT04672408    
Other Study ID Numbers: CER_GVA_2021
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Yareta data repository
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: At the ocmpletion of the study
Access Criteria: Open access for at least 15 years (as per Swiss law)

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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
Keywords provided by Haran Burri, MD, University Hospital, Geneva:
His bundle pacing
Right ventricular pacing
Left ventricular systolic function
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases