Prospective Assessment After Pediatric Cardiac Ablation (PAPCA)

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005553
• Other study ID #: 5097
• Secondary ID: R01HL058620
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: January 8, 2016
• Start date: May 1998
• Est. completion date: April 2004

Study information

• Verified date: October 2005
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Arrhythmia
• Cardiovascular Diseases
• Heart Diseases
• Tachycardia
• Tachycardia, Supraventicular

Intervention

Procedure:
• Catheter Ablation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (4)

Anand RG, Rosenthal GL, Van Hare GF, Snyder CS. Is the mechanism of supraventricular tachycardia in pediatrics influenced by age, gender or ethnicity? Congenit Heart Dis. 2009 Nov-Dec;4(6):464-8. doi: 10.1111/j.1747-0803.2009.00336.x. — View Citation

Van Hare GF, Carmelli D, Smith WM, Kugler J, Silka M, Friedman R, Atkins D, Saul P, Schaffer M, Byrum C, Dunnigan A, Colan S, Serwer G; Pediatric Electrophysiology Society. Prospective assessment after pediatric cardiac ablation: design and implementation of the multicenter study. Pacing Clin Electrophysiol. 2002 Mar;25(3):332-41. — View Citation

Van Hare GF, Javitz H, Carmelli D, Saul JP, Tanel RE, Fischbach PS, Kanter RJ, Schaffer M, Dunnigan A, Colan S, Serwer G; Participating Members of the Pediatric Electrophysiology Society. Prospective assessment after pediatric cardiac ablation: recurrence at 1 year after initially successful ablation of supraventricular tachycardia. Heart Rhythm. 2004 Jul;1(2):188-96. — View Citation

Van Hare GF, Javitz H, Carmelli D, Saul JP, Tanel RE, Fischbach PS, Kanter RJ, Schaffer M, Dunnigan A, Colan S, Serwer G; Pediatric Electrophysiology Society. Prospective assessment after pediatric cardiac ablation: demographics, medical profiles, and initial outcomes. J Cardiovasc Electrophysiol. 2004 Jul;15(7):759-70. — View Citation