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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by Roberto Costa, University of Sao Paulo.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01477658
First Posted: November 22, 2011
Last Update Posted: May 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Roberto Costa, University of Sao Paulo
  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

Resource links provided by NLM:


Further study details as provided by Roberto Costa, University of Sao Paulo:

Primary Outcome Measures:
  • Mortality [ Time Frame: 24 months after enrollment ]

Secondary Outcome Measures:
  • Echocardiogram and Clinical Composite [ Time Frame: baseline and 24 months after enrollment ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: November 18, 2011
First Posted: November 22, 2011
Last Update Posted: May 7, 2013
Last Verified: May 2013

Keywords provided by Roberto Costa, 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