Quality of Life in Patients Post Radiofrequency Ablation

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00165997
• Other study ID #: 0147-2004
• Status: Terminated
• Phase: N/A
• First received: September 12, 2005
• Last updated: December 9, 2013
• Start date: February 2004
• Est. completion date: October 2007

Study information

• Verified date: December 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmia
• Quality of Life
• Radiofrequency Catheter Ablation

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States,