Electrical and Mechanical Activation in PAcing The His Bundle Conduction sYstem

NCT ID: NCT05222672

Last Updated: 2022-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-01-07

Brief Summary

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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

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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.

Conditions

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Pacemaker DDD His Bundle Pacing Right Ventricular Pacing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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His Bundle Pacing

Pacing of the His bundle

Intervention Type OTHER

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of Ferrara

OTHER

Sponsor Role lead

Responsible Party

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Matteo Bertini

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matteo Bertini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Ferrara

Locations

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Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type RESULT
PMID: 36354776 (View on PubMed)

Other Identifiers

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CE-AVEC 457/2021/Oss/AOUFe

Identifier Type: -

Identifier Source: org_study_id

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