Prospective Assessment After Pediatric Cardiac Ablation (PAPCA)
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Arrhythmia
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Catheter Ablation
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005553
First Posted
May 25, 2000
Last Updated
January 8, 2016
Sponsor
Stanford University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005553
Brief Title
Prospective Assessment After Pediatric Cardiac Ablation (PAPCA)
Study Type
Observational
2. Study Status
Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
May 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Stanford University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Arrhythmia, Tachycardia, Supraventicular
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Catheter Ablation
10. Eligibility
Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Van Hare
Organizational Affiliation
Stanford University
12. IPD Sharing Statement
Citations:
PubMed Identifier
11990663
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. doi: 10.1046/j.1460-9592.2002.00332.x.
Results Reference
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PubMed Identifier
15250858
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. doi: 10.1046/j.1540-8167.2004.03645.x.
Results Reference
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PubMed Identifier
15851152
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. doi: 10.1016/j.hrthm.2004.03.067.
Results Reference
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PubMed Identifier
19925541
Citation
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.
Results Reference
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Prospective Assessment After Pediatric Cardiac Ablation (PAPCA)
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