Quality of Life in Patients Post Radiofrequency Ablation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00165997
Recruitment Status : Terminated (sufficient data collected for significant conclusive results)
First Posted : September 14, 2005
Last Update Posted : December 10, 2013
Information provided by (Responsible Party):
Margaret Strieper, Emory University

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.

Condition or disease
Radiofrequency Catheter Ablation Quality of Life Arrhythmia

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.

Study Type : Observational
Estimated Enrollment : 50 participants
Time Perspective: Prospective
Official Title: The Effects of Radiofrequency Ablation Procedures on Quality of Life in the Pediatric Cohort
Study Start Date : February 2004
Actual Study Completion Date : October 2007

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00165997

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

Responsible Party: Margaret Strieper, Principal Investigator, Emory University Identifier: NCT00165997     History of Changes
Other Study ID Numbers: 0147-2004
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013

Keywords provided by Margaret Strieper, Emory University:
Radiofrequency ablation
structurally normal heart