We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective Assessment After Pediatric Cardiac Ablation (PAPCA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005553
First Posted: May 26, 2000
Last Update Posted: January 12, 2016
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.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Stanford University
May 25, 2000
May 26, 2000
January 12, 2016
May 1998
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00005553 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prospective Assessment After Pediatric Cardiac Ablation (PAPCA)
Not Provided
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
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
  • Cardiovascular Diseases
  • Heart Diseases
  • Arrhythmia
  • Tachycardia, Supraventicular
Procedure: Catheter Ablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
April 2004
Not Provided
No eligibility criteria
Sexes Eligible for Study: All
up to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00005553
5097
R01HL058620 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
Not Provided
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
Investigator: George Van Hare Stanford University
Stanford University
October 2005