His Bundle Pacing Versus Right Ventricular Pacing

NCT ID: NCT04672408

Last Updated: 2025-04-09

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2025-04-04

Brief Summary

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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

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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.

Conditions

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Pacing-Induced Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized crossover double-blind
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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His bundle pacing

Pacing programmed from the His bundle lead

Group Type ACTIVE_COMPARATOR

His bundle pacing

Intervention Type DEVICE

Pacing with capture of the His bundle

Right ventricular pacing

Pacing programmed from the right ventricular lead

Group Type PLACEBO_COMPARATOR

Right ventricular pacing

Intervention Type DEVICE

Pacing from the right ventricular lead (septal or apical)

Interventions

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His bundle pacing

Pacing with capture of the His bundle

Intervention Type DEVICE

Right ventricular pacing

Pacing from the right ventricular lead (septal or apical)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Haran Burri, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Switzerland

Other Identifiers

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CER_GVA_2021

Identifier Type: -

Identifier Source: org_study_id

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