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Completed

NCT Number: NCT03452462

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

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.

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Key information

Conditions

Cardiac Pacing, Artificial Cardiac Resynchronization Therapy Direct His Bundle Pacing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Geneva

Geneva, Canton of Geneva, 1211, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pacing

Device

Programming of either Direct His Bundle pacing or biventricular pacing

Primary outcomes

  1. Left ventricular activation time

    Time frame: 5 minutes

    Duration of left ventricular electrical activation

Secondary outcomes

  1. Right ventricular activation time

    Time frame: 5 minutes

    Duration of right ventricular electrical activation

  2. Total ventricular activation time

    Time frame: 5 minutes

    Duration of total ventricular electrical activation

  3. Systolic pressure

    Time frame: 5 minutes

    Systolic blood pressure measured by finger plethysmography

  4. Cardiac output

    Time frame: 5 minutes

    Cardiac output measured by conductive velocimetry

  5. Cardiac contractility

    Time frame: 5 minutes

    Cardiac contractilit measured by conductive velocimetry

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • Swiss National Fund for Scientific Research

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 2, 2018
Registry last updated
Dec 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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