Congenital Complete Atrioventricular Heart Block Clinical Trial
Official title:
Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block
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.
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:
1. 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;
2. 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;
3. Evaluation of ventricular function and cardiac synchronicity: Tissue Doppler (TDI) and
real-time three-dimensional echocardiography (RT3DE);
4. 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
;
Observational Model: Cohort, Time Perspective: Prospective