Electrical and Mechanical Activation in PAcing The His Bundle Conduction sYstem

In recent years, the finding of long-term deleterious effects of right ventricular pacing (RVP) has led to an ongoing search for alternative pacing sites such as His bundle stimulation. The depolarization of the ventricles through the His-Purkinje cardiac conduction system seems to represent an ideal physiological approach to ventricular pacing, capable of engaging the normal conduction pathways and determining synchronous ventricular activation. However, there are still no clinical studies that have evaluated the electromechanical functions of the left ventricle with His bundle pacing (HBP) identified after electroanatomical reconstruction with 3D mapping system. Investigators aimed to compare the electromechanical effects on left ventricle of HBP, compared to RVP stimulation and to spontaneous rhythm of each patient.

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Key information

Conditions

Pacemaker Ddd His Bundle Pacing Right Ventricular Pacing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, 44124, Italy

About this study

Patients with indication for permanent pacemaker implantation were included in the study. The stimulation lead was positioned at the level of the His bundle after complete electroanatomical reconstruction of the atrium and right ventricle with 3D mapping system; a second backup lead was eventually placed in the right ventricle. Within 24 hours after implantation, each patient underwent 12-lead ECG and a complete echocardiographic examination in the different pacing modalities (HBP, RVP and patient's spontaneous rhythm) focused on the evaluation of biventricular systo-diastolic function, speckle-tracking and myocardial work of the left ventricle.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with indication of class I or class IIa for permanent pacemaker implantation, in accordance with the guidelines of the European Society of Cardiology on cardiac pacing
Age ≥ 18 years
Written consent

Exclusion criteria

Patients unable to express informed consent
Pregnancy
Severe mitro-aortic valve disease
Left ventricular ejection fraction ≤ 35%

Treatment and study plan

His Bundle Pacing

Other

Pacing of the His bundle

Primary outcomes

Evaluate the electrocardiographic differences of HBP, obtained by electroanatomical reconstruction with 3D mapping system, compared to the RVP and the patient's spontaneous rhythm.

Time frame: 24 hours after implantation

Measurement of QRS width (msec) in 12-lead electrocardiogram
Evaluate the echocardiographic differences of HBP, obtained by electroanatomical reconstruction with 3D mapping system, compared to the RVP and the patient's spontaneous rhythm.

Time frame: 24 hours after implantation

Transthoracic echocardiogram measurement such as left ventricular systolic function (%), left ventricular Global Longitudinal Strain (GLS %), tissue doppler and severity of any valve disease

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Official study title

Electrical and Mechanical Activation in PAcing The His Bundle Conduction sYstem: EMPATHY Study

Acronym: EMPATHY

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Feb 3, 2022
Registry last updated: Nov 30, 2022

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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