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Prospective Assessment After Pediatric Cardiac Ablation (PAPCA)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00005553
First received: May 25, 2000
Last updated: January 8, 2016
Last verified: October 2005
  Purpose
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.

Condition Intervention
Cardiovascular Diseases Heart Diseases Arrhythmia Tachycardia, Supraventicular Procedure: Catheter Ablation

Study Type: Observational

Further study details as provided by Stanford University:

Study Start Date: May 1998
Estimated Study Completion Date: April 2004
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005553

Sponsors and Collaborators
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: George Van Hare Stanford University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005553     History of Changes
Other Study ID Numbers: 5097
R01HL058620 ( US NIH Grant/Contract Award Number )
Study First Received: May 25, 2000
Last Updated: January 8, 2016

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

ClinicalTrials.gov processed this record on June 23, 2017