Prospective Assessment After Pediatric Cardiac Ablation (PAPCA)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005553
First received: May 25, 2000
Last updated: February 25, 2010
Last verified: October 2005

May 25, 2000
February 25, 2010
May 1998
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Complete list of historical versions of study NCT00005553 on ClinicalTrials.gov Archive Site
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Prospective Assessment After Pediatric Cardiac Ablation (PAPCA)
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To evaluate children undergoing catheter ablation at pediatric centers in North America in order to provide information on the incidence rate of serious cardiac damage as a result of ablation, the incidence rate and time course of recurrence after initially successful ablation, and the incidence rate of proarrhythmia following ablation.

BACKGROUND:

Radiofrequency catheter ablation is a catheterization laboratory technique for the cure of cardiac arrhythmias, which has become common in pediatric cardiology practice. Recent analyses have suggested that ablation therapy is more cost-effective compared not only with surgery, but also with antiarrhythmic medication. Despite a good initial success rate of the technique, and a low initial complication rate, there is concern about possible long-term effects with the technique in the pediatric age group. There are reports not only of damage to cardiac valves, but also the development of new arrhythmias, including sudden death, as a result of ablations in children. Recurrences are observed frequently following initially successful procedures. Finally, there are animal data to suggest that immature myocardium is more prone to severe damage as a result of ablation procedures. Few, if any, data exist to support the long-term safety of these ablation techniques in children. Therefore, before ablation therapy becomes the standard approach in children, it is important to carefully assess the long-term risks in this patient group.

DESIGN NARRATIVE:

Multi-center, prospective, five-year study. The collection of these data was intended to provide the following information: 1) the incidence of serious cardiac damage as a result of ablation; 2) the incidence and time course of recurrence after initially successful ablation; and 3) the incidence of proarrhythmia following ablation. A total of 480 pediatric patients were enrolled prospectively and evaluated both before ablation of supraventricular tachycardia and at intervals following ablation with clinical history and examination, electrocardiogram, 24-hour Holter monitor, and echocardiogram, with non-invasive studies read by outside consultants. In addition, a complete Registry of pediatric patients undergoing ablation at the participating centers was established to allow comparisons with the study group and to provide population estimates of success and complication rates.

Observational
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  • Cardiovascular Diseases
  • Heart Diseases
  • Arrhythmia
  • Tachycardia, Supraventicular
Procedure: Catheter Ablation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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April 2004
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No eligibility criteria

Both
up to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00005553
5097
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: George Van Hare Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP