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

Not Applicable

Completed

• Conditions: Cardiac Resynchronization Therapy; Direct His Bundle Pacing; Cardiac Pacing, Artificial
• Interventions: Device: Pacing

• Registration Number: NCT03452462
• Lead Sponsor: University Hospital, Geneva

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-02-25
• Study First Submitted QC: 2018-02-25
• Study First Posted: 2018-03-02
• Study Start: 2019-04-01
• Primary Completion: 2020-08-30
• Status Verified: 2020-11
• Study Completion: 2020-11-26
• Last Update Submitted: 2020-11-28
• Last Update Posted: 2020-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Direct His Bundle Pacing	Pacing	Pacing from the His bundle lead
Biventricular Pacing	Pacing	Pacing from the right ventricular and coronary sinus leads

Primary Outcome Measures

Name	Time	Method
Left ventricular activation time	5 minutes	Duration of left ventricular electrical activation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Geneva; 🇨🇭 Geneva, GE, Switzerland