Electrical and Mechanical Activation in PAcing The His Bundle Conduction sYstem

Pacemaker DDD Clinical Trial

— EMPATHY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05222672
• Other study ID #: CE-AVEC 457/2021/Oss/AOUFe
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: January 7, 2022

Study information

• Verified date: November 2022
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 7, 2022
• Est. primary completion date: January 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• His Bundle Pacing
• Pacemaker DDD
• Right Ventricular Pacing

Intervention

Other:
• His Bundle Pacing
Pacing of the His bundle

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria di Ferrara	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Malagu M, Vitali F, Massafra RF, Cardelli LS, Pavasini R, Guardigli G, Rapezzi C, Bertini M. Three-Dimensional Electro-Anatomical Mapping and Myocardial Work Performance during Spontaneous Rhythm, His Bundle Pacing and Right Ventricular Pacing: The EMPATH — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the electrocardiographic differences of HBP, obtained by electroanatomical reconstruction with 3D mapping system, compared to the RVP and the patient's spontaneous rhythm.	Measurement of QRS width (msec) in 12-lead electrocardiogram	24 hours after implantation
Primary	Evaluate the echocardiographic differences of HBP, obtained by electroanatomical reconstruction with 3D mapping system, compared to the RVP and the patient's spontaneous rhythm.	Transthoracic echocardiogram measurement such as left ventricular systolic function (%), left ventricular Global Longitudinal Strain (GLS %), tissue doppler and severity of any valve disease	24 hours after implantation