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Clinical Trials/NCT00165997
NCT00165997
Terminated
Not Applicable

The Effects of Radiofrequency Ablation Procedures on Quality of Life in the Pediatric Cohort

Emory University1 site in 1 country50 target enrollmentFebruary 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Radiofrequency Catheter Ablation
Sponsor
Emory University
Enrollment
50
Locations
1
Status
Terminated
Last Updated
12 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 2004
End Date
October 2007
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Margaret Strieper

Principal Investigator

Emory University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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