Electrical and Mechanical Activation in PAcing The His Bundle Conduction sYstem

NCT05222672 | Completed

• 1 other identifier: CE-AVEC 457/2021/Oss/AOUFe
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pacemaker DDD; His Bundle Pacing; Right Ventricular Pacing

Keywords

3D mapping system; Myocardial work; Mechanical dyssynchrony; 12-lead Electrocardiogram; Speckle-tracking echocardiography

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

His Bundle Pacing OTHER

Pacing of the His bundle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients over the age of 18 years with indication for permanent pacemaker implantation.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, 44124, Italy

Location

Related 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 EMPATHY Study. J Cardiovasc Dev Dis. 2022 Nov 2;9(11):377. doi: 10.3390/jcdd9110377.

  PMID: 36354776 RESULT

Study Officials

• Matteo Bertini, MD, PhD

  Università degli Studi di Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: February 3, 2022
• Study Start: February 1, 2021
• Primary Completion: January 7, 2022
• Study Completion: January 7, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

IT (1)