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.

Study Overview

• Status: Completed
• Conditions: Cardiac Resynchronization Therapy; Cardiac Pacing, Artificial; Direct His Bundle Pacing
• Intervention / Treatment: Device: Pacing

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • GE
    • Geneva, GE, Switzerland, 1211
      • University Hospital Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Direct His Bundle Pacing; Pacing from the His bundle lead	Device: Pacing; Programming of either Direct His Bundle pacing or biventricular pacing
ACTIVE_COMPARATOR: Biventricular Pacing; Pacing from the right ventricular and coronary sinus leads	Device: Pacing; Programming of either Direct His Bundle pacing or biventricular pacing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular activation time	Duration of left ventricular electrical activation	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right ventricular activation time	Duration of right ventricular electrical activation	5 minutes
Total ventricular activation time	Duration of total ventricular electrical activation	5 minutes
Systolic pressure	Systolic blood pressure measured by finger plethysmography	5 minutes
Cardiac output	Cardiac output measured by conductive velocimetry	5 minutes
Cardiac contractility	Cardiac contractilit measured by conductive velocimetry	5 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: Swiss National Fund for Scientific Research

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ACTUAL): August 30, 2020
• Study Completion (ACTUAL): November 26, 2020

Study Registration Dates

• First Submitted: February 25, 2018
• First Submitted That Met QC Criteria: February 25, 2018
• First Posted (ACTUAL): March 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 1, 2020
• Last Update Submitted That Met QC Criteria: November 28, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HisCRT_GVA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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