Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
29 participants
INTERVENTIONAL
2021-08-01
2025-04-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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His bundle pacing
Pacing programmed from the His bundle lead
His bundle pacing
Pacing with capture of the His bundle
Right ventricular pacing
Pacing programmed from the right ventricular lead
Right ventricular pacing
Pacing from the right ventricular lead (septal or apical)
Interventions
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His bundle pacing
Pacing with capture of the His bundle
Right ventricular pacing
Pacing from the right ventricular lead (septal or apical)
Eligibility Criteria
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Inclusion Criteria
* Standard pacing indication with \>20% VP
* Functional His bundle lead with confirmed His capture
* Functional right ventricular lead with myocardial capture
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospital, Geneva
OTHER
Responsible Party
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Haran Burri, MD
Professor
Principal Investigators
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Haran Burri, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Geneva
Locations
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University Hospital Geneva
Geneva, Canton of Geneva, Switzerland
Countries
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Other Identifiers
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CER_GVA_2021
Identifier Type: -
Identifier Source: org_study_id
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