- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00165997
Quality of Life in Patients Post Radiofrequency Ablation
December 9, 2013 updated by: Margaret Strieper, Emory University
The Effects of Radiofrequency Ablation Procedures on Quality of Life in the Pediatric Cohort
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.
Study Overview
Status
Terminated
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
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Margaret J Strieper, DO, Emory University and Children's Healthcare of Atlanta
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
December 10, 2013
Last Update Submitted That Met QC Criteria
December 9, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 0147-2004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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