Quality of Life in Patients Post Radiofrequency Ablation

This study has been terminated.
(sufficient data collected for significant conclusive results)
Sponsor:
Information provided by (Responsible Party):
Margaret Strieper, Emory University
ClinicalTrials.gov Identifier:
NCT00165997
First received: September 12, 2005
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition
Radiofrequency Catheter Ablation
Quality of Life
Arrhythmia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Effects of Radiofrequency Ablation Procedures on Quality of Life in the Pediatric Cohort

Further study details as provided by Emory University:

Estimated Enrollment: 50
Study Start Date: February 2004
Study Completion Date: October 2007
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.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165997

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Margaret J Strieper, DO Emory University and Children's Healthcare of Atlanta
  More Information

No publications provided

Responsible Party: Margaret Strieper, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00165997     History of Changes
Other Study ID Numbers: 0147-2004
Study First Received: September 12, 2005
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
pediatrics
cardiology
Radiofrequency ablation
structurally normal heart

ClinicalTrials.gov processed this record on September 18, 2014