Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block

Study Overview
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Brief Summary
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Recent studies have shown that chronic stimulation of the right ventricle can cause deleterious effects to cardiac function and synchronicity. The occurrence and consequences of this phenomenon in children and young patients with cardiac pacemaker due to advanced atrioventricular block (AVB) are still unknown. Thus, our aims is to assess the chronic effects of cardiac pacing in children and young patients with advanced AVB and its impact on clinical, functional and echocardiographic parameters.

Detailed Description
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This is a prospective cohort study that will include patients younger than 18 years-old at initial pacemaker implantation due to advanced AVB. The design of the study will involve the following stages: Screening and enrollment: patients will be selected consecutively during ambulatory care at our Institution or by the database of the Surgical Unity of Cardiac Pacing; Clinical and laboratory evaluation: patient history, clinical evaluation, serum levels of neurohormonal and inflammatory biomarkers of heart failure, clinical and laboratory investigation of autoimmune rheumatic diseases, quality of life (SF-36, CHQ-PF50) and six-minute walk test; Evaluation of ventricular function and cardiac synchronicity: Tissue Doppler (TDI) and real-time three-dimensional echocardiography (RT3DE); Follow-up: patients will be monitored during 24 months. The main end-points are: Clinical and functional changes (NYHA functional class) Heart failure hospitalization Quality of life Overall and cardiac mortality Cardiac resynchronization therapy and heart transplantation

Official Title
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Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block

Conditions
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Congenital Complete Atrioventricular Heart Block, High Grade Atrioventricular Block, Postoperative Complete Heart Block

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age <18 years at initial pacemaker implantation Advanced AV block with /without congenital heart defects Time under cardiac pacing superior than one year Unicameral or atrioventricular pacing in single right ventricle site Informed consent of the patient or responsible Exclusion Criteria: Bifocal or biventricular pacing Discontinuing use of the device for recovery of atrioventricular conduction Cardiac transplantation Inability to participate in the study procedures
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Congenital AV Block<br>Patients diagnosed with Congenital Complete Atrioventricular Heart Block | |
| Postoperative AV Block<br>Patients diagnosed with postoperative AV block | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 24 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiogram and Clinical Composite |  | baseline and 24 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital Complete Atrioventricular Heart Block, Pacemaker, Cardiac pacing, Children, Heart failure, Ventricular dyssynchrony, Echocardiography, Quality of life, Six-minute walk test, Young adults