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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Roberto Costa, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01477658
First received: November 18, 2011
Last updated: May 4, 2013
Last verified: May 2013
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Mortality [ Time Frame: 24 months after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Echocardiogram and Clinical Composite [ Time Frame: baseline and 24 months after enrollment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood


Enrollment: 140
Study Start Date: November 2007
Estimated Study Completion Date: November 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Congenital AV Block
Patients diagnosed with Congenital Complete Atrioventricular Heart Block
Postoperative AV Block
Patients diagnosed with postoperative AV block

Detailed 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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Ambulatory Care

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477658

Locations
Brazil
Heart Institute (InCor) of University of São Paulo Medical School (Brazil)
Sao Paulo, Brazil, 05403000
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Chair: Roberto Costa, MD, PhD University of Sao Paulo
Principal Investigator: Roberto M Oliveira Jr, MD University of Sao Paulo
  More Information

No publications provided

Responsible Party: Roberto Costa, Associated Professor of Cardiovascular Surgery, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01477658     History of Changes
Other Study ID Numbers: CAPPesq nº 1248/09
Study First Received: November 18, 2011
Last Updated: May 4, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Congenital Complete Atrioventricular Heart Block
Pacemaker
Cardiac pacing
Children
Heart failure
Ventricular dyssynchrony
Echocardiography
Quality of life
Six-minute walk test
Young adults

Additional relevant MeSH terms:
Atrioventricular Block
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014