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Electrical Resynchronization and Acute Hemodynamic Effects of Direct His Bundle Pacing Compared to Biventricular Pacing

NCT ID: NCT03452462

Last Updated: 2020-12-01

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

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-11-26

Brief Summary

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The aims are to compare Direct His Bundle Pacing (DHBP) with biventricular pacing (BiV) in terms of electrical resynchronization using electrocardiographic imaging (ECGI) and also in terms of acute hemodynamical effect using finger plethysmography and conduction velocimetry. The study will be a randomized crossover design with acute measurements.

Detailed Description

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By recruiting native conducting tissue to relay electrical activation of the ventricles via the Purkinje fibre network, DHBP may potentially achieve greater electrical resynchronization and hemodynamic benefit compared to BiV where the electrical activation wavefronts propagate from two discrete pacing sites. Electrical synchrony achieved by these pacing modes have however never been compared. Furthermore, the acute hemodynamic effect of DHBP has been compared to BiV only in a small single study to date. The aims are to compare DHBP with BiV in terms of electrical resynchronization using electrocardiographic imaging (ECGI) and also in terms of acute hemodynamical effect using finger plethysmography and conduction velocimetry. The primary endpoint will be left ventricular activation time, with secondary endpoints including various electrical (right ventricular activation time, total ventricular activation time etc) and hemodynamic parameters (systolic pressure, cardiac output, cardiac contractility). It is expected that DHBP offers shorter left ventricular activation time (i.e. better synchrony) and hemodynamic benefit compared to BiV.

Conditions

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Cardiac Pacing, Artificial Cardiac Resynchronization Therapy Direct His Bundle Pacing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Direct His Bundle Pacing

Pacing from the His bundle lead

Group Type EXPERIMENTAL

Pacing

Intervention Type DEVICE

Programming of either Direct His Bundle pacing or biventricular pacing

Biventricular Pacing

Pacing from the right ventricular and coronary sinus leads

Group Type ACTIVE_COMPARATOR

Pacing

Intervention Type DEVICE

Programming of either Direct His Bundle pacing or biventricular pacing

Interventions

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Pacing

Programming of either Direct His Bundle pacing or biventricular pacing

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Treatment of heart failure with a standard indication for CRT (NYHA III-IV, LVEF \< 35% and QRS \> 130ms; or LVEF\< 40% and requirement for frequent ventricular pacing, irrespective of baseline QRS duration) and optimal medical treatment.

* Permanent atrial fibrillation (allowing connection of the DHBP lead to the atrial port).
* Patients implanted with 1) a CRT pacemaker or CRT defibrillator 2) a His lead with selective or non-selective DHBP, connected to the atrial port of the generator 3) a functional right ventricular lead and 4) a functional coronary sinus lead.
* DHBP with selective or non-selective His capture

Exclusion Criteria

* Age \<18 years
* Pregnancy
* Inability to undergo CT or an MRI (e.g. due to severe claustrophobia)
* Inability or refusal to sign the patient informed consent form.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss National Fund for Scientific Research

OTHER

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Haran Burri, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Geneva

Geneva, Canton of Geneva, Switzerland

Site Status

Countries

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Switzerland

References

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Zweerink A, Zubarev S, Bakelants E, Potyagaylo D, Stettler C, Chmelevsky M, Lozeron ED, Hachulla AL, Vallee JP, Burri H. His-Optimized Cardiac Resynchronization Therapy With Ventricular Fusion Pacing for Electrical Resynchronization in Heart Failure. JACC Clin Electrophysiol. 2021 Jul;7(7):881-892. doi: 10.1016/j.jacep.2020.11.029. Epub 2021 Feb 24.

Reference Type DERIVED
PMID: 33640346 (View on PubMed)

Other Identifiers

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HisCRT_GVA

Identifier Type: -

Identifier Source: org_study_id