Quality of Life in Patients Post Radiofrequency Ablation

NCT ID: NCT00165997

Last Updated: 2013-12-10

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2007-10-31

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.

Conditions

Radiofrequency Catheter Ablation; Quality of Life; Arrhythmia

Study Design

• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Margaret Strieper

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margaret J Strieper, DO

Role: PRINCIPAL_INVESTIGATOR

Emory University and Children's Healthcare of Atlanta

Locations

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

0147-2004

Identifier Type: -

Identifier Source: org_study_id