Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165997
Status:
TERMINATED
Last Update Posted:
2013-12-10
First Post:
2005-09-12
Brief Title:
Quality of Life in Patients Post Radiofrequency Ablation
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
The Effects of Radiofrequency Ablation Procedures on Quality of Life in the Pediatric Cohort
Status:
TERMINATED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
sufficient data collected for significant conclusive results
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Childrens 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 40 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None