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Quality of Life in Patients Post Radiofrequency Ablation

This study has been terminated.
(sufficient data collected for significant conclusive results)
Sponsor:
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00165997
First received: September 12, 2005
Last updated: December 7, 2007
Last verified: December 2007
History of Changes

September 12, 2005
December 7, 2007
February 2004
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Complete list of historical versions of study NCT00165997 on ClinicalTrials.gov Archive Site
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Quality of Life in Patients Post Radiofrequency Ablation
The Effects of Radiofrequency Ablation Procedures on Quality of Life in the Pediatric Cohort

Radiofrequency ablation is a procedure done in the Catheterization Laboratory to help correct specific problems that cause the heart to beat faster than it should. Quality of life includes the physical as well as the emotional aspects of a patient. Doctors have always tried to take care of a medical problem with minimal physical and emotional risk. It is assumed that once the medical problem is fixed, the patient will have an improved quality of life. To know if this assumption is true, the investigators are asking children scheduled for this procedure, along with their family, to answer questions before the ablation, then answer the same questions 5-6 months after the ablation.

When a patient (age 5-18 years) is scheduled for an ablation at Children's Healthcare of Atlanta, the research coordinator contacts the family prior to the procedure and describes the study to them, details the goals, benefits versus risks, and answers any questions they may have. Written consent is obtained from the parents. Assent is obtained from the child. Both the parent and child are given the age appropriate Peds QL (tm) Pediatric Quality of Life Inventory, version 4.0. The forms are returned to the research coordinator. If the child is ablated, then 5-6 months after the ablation, the same questionnaire is sent to the child and parent. Data are entered into a database.
Observational
Time Perspective: Prospective
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  • Radiofrequency Catheter Ablation
  • Quality of Life
  • Arrhythmia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
October 2007
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Inclusion Criteria:

  • 5-18 years of age
  • English is the primary language
  • Scheduled for an ablation at Children's Healthcare of Atlanta
  • Normally structured heart

Exclusion Criteria:

  • Congenital heart defect
  • English is not the primary language
  • Children with significant neurocognitive deficits as determined by the investigator
Both
5 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00165997
147-2004
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Emory University
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Principal Investigator: Margaret J Strieper, DO Emory University and Children's Healthcare of Atlanta
Emory University
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP