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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
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 16 Years (Child)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    January 8, 2016
    Sponsor
    Stanford University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    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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