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

Congenital Complete Atrioventricular Heart Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01477658
• Other study ID #: CAPPesq nº 1248/09
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 18, 2011
• Last updated: May 4, 2013
• Start date: November 2007
• Est. completion date: November 2013

Study information

• Verified date: May 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 140
• Est. completion date: November 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrioventricular Block
• Congenital Complete Atrioventricular Heart Block
• Heart Block
• High Grade Atrioventricular Block
• Postoperative Complete Heart Block

Locations

Country	Name	City	State
Brazil	Heart Institute (InCor) of University of São Paulo Medical School (Brazil)	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		24 months after enrollment	No
Secondary	Echocardiogram and Clinical Composite		baseline and 24 months after enrollment	No