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

Sponsor

University Hospital, Geneva (Other)

Overall Status

Completed

CT.gov ID

NCT03452462

Collaborator

Swiss National Fund for Scientific Research (Other)

Enrollment

Location

Arms

19.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Pacing, Artificial Cardiac Resynchronization Therapy Direct His Bundle Pacing	Device: Pacing	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2019

Actual Primary Completion Date :

Aug 30, 2020

Actual Study Completion Date :

Nov 26, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Left ventricular activation time [5 minutes]
Duration of left ventricular electrical activation

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Geneva	Geneva	GE	Switzerland	1211

Sponsors and Collaborators

University Hospital, Geneva
Swiss National Fund for Scientific Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Haran Burri, MD, Professor, University Hospital, Geneva

ClinicalTrials.gov Identifier:

NCT03452462

Other Study ID Numbers:

HisCRT_GVA

First Posted:

Mar 2, 2018

Last Update Posted:

Dec 1, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Dec 1, 2020