Electrical and Mechanical Activation in PAcing The His Bundle Conduction sYstem

Completed

• Conditions: Pacemaker DDD; His Bundle Pacing; Right Ventricular Pacing

• Registration Number: NCT05222672
• Lead Sponsor: University Hospital of Ferrara

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2022-01-07
• Study Completion: 2022-01-07
• Study First Submitted: 2022-01-17
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-03
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-25
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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%

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the echocardiographic differences of HBP, obtained by electroanatomical reconstruction with 3D mapping system, compared to the RVP and the patient's spontaneous rhythm.	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
Evaluate the electrocardiographic differences of HBP, obtained by electroanatomical reconstruction with 3D mapping system, compared to the RVP and the patient's spontaneous rhythm.	24 hours after implantation	Measurement of QRS width (msec) in 12-lead electrocardiogram

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria di Ferrara; 🇮🇹 Ferrara, Italy