Congenital DisordersNCT00267982
Radiofrequency Ablation of Ectopic Atrial Tachycardia
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
A retrospective chart review will be performed on 50 patients who received RFA for the treatment of EAT between August 1992 and August 2003 at Children's Healthcare of Atlanta. The use of the CARTO/Biosense catheter has improved outcomes with decreased radiation exposure to patients. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Congenital Disorders
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1992to Feb 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population is subjects received RFA for treatment of EAT between August 2992 and August 2003 at Children's Healthcare of Atlanta
Who may be able to join
- 50 patients who received RFA for treatment of EAT between August 2992 and August 2003
- Treatment at Children's Healthcare of Atlanta
Who cannot join
- those who do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: A Retrospective Review of Outcomes Related to Radiofrequency Ablation of Ectopic Atrial Tachycardia
A retrospective chart review will be performed on 50 patients who received RFA for the treatment of EAT between August 1992 and August 2003 at Children's Healthcare of Atlanta.
The use of the CARTO/Biosense catheter has improved outcomes with decreased radiation exposure to patients.
Read the detailed description
Ectopic Atrial Tachycardia (EAT) is a relatively rare arrhythmia in the pediatric population. It is defined by a run of more than 3 premature atrial contractions together. In EAT, the arrhythmia tends to increase in rate over a period of time and then slows down gradually to a normal rhythm. Ectopic Atrial Tachycardia (EAT) is mostly encountered in patients with structurally normal hearts however, occasionally physicians do observe this type of disorder in children following surgery for congenital heart defects. Current reports suggest that EAT occurs in approximately 1 in 10,000 children (Hamilton, 2002).
Children with EAT usually present with a multitude of symptoms. The most common symptoms associated with pediatric EAT are palpitations, chest pain, lightheadedness, presyncope, and dyspnea. Other symptoms can include exercise intolerance and congestive heart failure. These are usually late manifestations. In the patients with tachycardia induced CM, the time of development of CM is dependent on the rate and duration of the tachycardia however, in most cases, dilation is present upon diagnosis. This CM can be reversed with successful treatment of the arrhythmia.
The treatment for chronic EAT includes medications such as adenosine and for difficult to control cases, Radiofrequency Ablation (RFA). RF ablation has been successful in curing EAT, with success rates ranging from 75-100%. It has been shown that the complication rates are similar to other RF ablation procedures, with a higher risk of recurrence (Hamilton, 2002).
At Children's Healthcare of Atlanta, the cardiac catheterization lab performs approximately 10 Radiofrequency ablations for EAT each year. The goal of this retrospective review is to assess the frequency of recurrence of the EAT among a subset of patients receiving treatment between August 1992 - August 2003
- Conditions
- Congenital Disorders
- Keywords
- pediatric, cardiac, Radiofrequency Ablation, Ectopic Atrial Tachycardia
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Tachycardia, Ectopic Atrial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
- Study startAug 1992
- Primary completionAug 2003
- Study completionFeb 2008
Why it stopped: significant conclusive data has been collected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Investigators
- Patrick A Frias, MD, Principal investigator, Sibley Heart Center Cardiology of Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267982
- Sponsor's protocol ID
- 03-064
- Status last verified
- Jun 2011
- First submitted
- 20 Dec 2005
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Review of Outcomes Related to Radiofrequency Ablation of Ectopic Atrial Tachycardia
- ClinicalTrials.gov ID
- NCT00267982
- Acronym / sponsor ID
- 03-064
- Conditions
- Congenital Disorders
- Keywords
- pediatric, cardiac, Radiofrequency Ablation, Ectopic Atrial Tachycardia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: significant conclusive data has been collected
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Aug 1992
- Primary completion
- Aug 2003 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 22 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A retrospective chart review will be performed on 50 patients who received RFA for the treatment of EAT between August 1992 and August 2003 at Children's Healthcare of Atlanta.
The use of the CARTO/Biosense catheter has improved outcomes with decreased radiation exposure to patients.
Detailed description
Ectopic Atrial Tachycardia (EAT) is a relatively rare arrhythmia in the pediatric population. It is defined by a run of more than 3 premature atrial contractions together. In EAT, the arrhythmia tends to increase in rate over a period of time and then slows down gradually to a normal rhythm. Ectopic Atrial Tachycardia (EAT) is mostly encountered in patients with structurally normal hearts however, occasionally physicians do observe this type of disorder in children following surgery for congenital heart defects. Current reports suggest that EAT occurs in approximately 1 in 10,000 children (Hamilton, 2002).
Children with EAT usually present with a multitude of symptoms. The most common symptoms associated with pediatric EAT are palpitations, chest pain, lightheadedness, presyncope, and dyspnea. Other symptoms can include exercise intolerance and congestive heart failure. These are usually late manifestations. In the patients with tachycardia induced CM, the time of development of CM is dependent on the rate and duration of the tachycardia however, in most cases, dilation is present upon diagnosis. This CM can be reversed with successful treatment of the arrhythmia.
The treatment for chronic EAT includes medications such as adenosine and for difficult to control cases, Radiofrequency Ablation (RFA). RF ablation has been successful in curing EAT, with success rates ranging from 75-100%. It has been shown that the complication rates are similar to other RF ablation procedures, with a higher risk of recurrence (Hamilton, 2002).
At Children's Healthcare of Atlanta, the cardiac catheterization lab performs approximately 10 Radiofrequency ablations for EAT each year. The goal of this retrospective review is to assess the frequency of recurrence of the EAT among a subset of patients receiving treatment between August 1992 - August 2003
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population is subjects received RFA for treatment of EAT between August 2992 and August 2003 at Children's Healthcare of Atlanta
Key inclusion criteria (2 listed)
- 50 patients who received RFA for treatment of EAT between August 2992 and August 2003
- Treatment at Children's Healthcare of Atlanta
Key exclusion criteria (1 listed)
- those who do not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: significant conclusive data has been collected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick A Frias, MD principal investigator
Sibley Heart Center Cardiology of Children's Healthcare of Atlanta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: significant conclusive data has been collected). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2011.