Clinical trial NCT05222672: Electrical and Mechanical Activation in PAcing The His Bundle Conduction sYstem
Official title: Electrical and Mechanical Activation in PAcing The His Bundle Conduction sYstem: EMPATHY Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pacemaker DDD
His Bundle Pacing
Right Ventricular Pacing
Keywords: 3D mapping system
Myocardial work
Mechanical dyssynchrony
12-lead Electrocardiogram
Speckle-tracking echocardiography
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over the age of 18 years with indication for permanent pacemaker implantation.

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.

Eligibility criteria: 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%

Primary outcomes:
measure: Evaluate the electrocardiographic differences of HBP, obtained by electroanatomical reconstruction with 3D mapping system, compared to the RVP and the patient's spontaneous rhythm.
timeFrame: 24 hours after implantation
measure: Evaluate the echocardiographic differences of HBP, obtained by electroanatomical reconstruction with 3D mapping system, compared to the RVP and the patient's spontaneous rhythm.
timeFrame: 24 hours after implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara
Study officials:
affiliation: Università degli Studi di Ferrara
name: Matteo Bertini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 EMPATHY Study. J Cardiovasc Dev Dis. 2022 Nov 2;9(11):377. doi: 10.3390/jcdd9110377.