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

Cardiac Resynchronization Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03452462
• Other study ID #: HisCRT_GVA
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: November 26, 2020

Study information

• Verified date: November 2020
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 26, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Pacing, Artificial
• Cardiac Resynchronization Therapy
• Direct His Bundle Pacing

Intervention

Device:
• Pacing
Programming of either Direct His Bundle pacing or biventricular pacing

Locations

Country	Name	City	State
Switzerland	University Hospital Geneva	Geneva	GE

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	Swiss National Fund for Scientific Research

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular activation time	Duration of left ventricular electrical activation	5 minutes
Secondary	Right ventricular activation time	Duration of right ventricular electrical activation	5 minutes
Secondary	Total ventricular activation time	Duration of total ventricular electrical activation	5 minutes
Secondary	Systolic pressure	Systolic blood pressure measured by finger plethysmography	5 minutes
Secondary	Cardiac output	Cardiac output measured by conductive velocimetry	5 minutes
Secondary	Cardiac contractility	Cardiac contractilit measured by conductive velocimetry	5 minutes