Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005553
Status:
COMPLETED
Last Update Posted:
2016-01-12
First Post:
2000-05-25
Brief Title:
Prospective Assessment After Pediatric Cardiac Ablation PAPCA
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL058620 | NIH | None | httpsreporternihgovquickSearchR01HL058620 |