Congenital DisordersNCT00238823
Cryoablation Versus Radiofrequency Ablation
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
The purpose of this retrospective study is to describe why and when we used cryo and why we crossed over when we used both RFA and cryo. It is also to determine if there is some predictor that would make us say one patient would be better served with one technique than another and to describe our overall acute success… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Disorders
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Dec 2004
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- charts between January 1 and 2004 to December 31, 2004
- pediatric population
- those who were ablated
Who cannot join
- -
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 Review and Comparison of Cryoablation and Radiofrequency Ablation in Children
The purpose of this retrospective study is to describe why and when we used cryo and why we crossed over when we used both RFA and cryo. It is also to determine if there is some predictor that would make us say one patient would be better served with one technique than another and to describe our overall acute success rate and then our 6-month recurrence rate with cryo ablation and compare it to our known success rate with RFA.
Read the detailed description
Cryotherapy (Cryo) is a new ablation energy source used instead of the radiofrequency (RFA) method for ablation of septal pathways. In the past year, we have used cryo approximately 50 times, however 50% of the cryo procedures crossed over from RFA to cryo or cryo to RFA. It appears to me that cryo use should be as an adjunct therapy to RFA instead of replacement of RFA.
I would like to describe why and when we used cryo and why we crossed over when we used both RFA and cryo. I would like to determine if there is some predictor that would make us say one patient would be better served with one technique than another. I would also describe our overall acute success rate and then our 6-month recurrence rate with cryo ablation and compare it to our known success rate with RFA. All of this can be done with a chart review.
This will be done through a retrospective study.
- Conditions
- Congenital Disorders
- Keywords
- cryoablation, radiofrequency ablation, pediatrics, cardiology
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2005 (estimated)
- Study startJan 2004
- Study completionDec 2004
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
- Defined population
- Time perspective
- Retrospective
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Investigators
- Margaret Strieper, DO, Principal investigator, Sibley Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238823
- Sponsor's protocol ID
- 05-108
- Status last verified
- May 2007
- First submitted
- 12 Oct 2005
- Last updated
- 23 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Review and Comparison of Cryoablation and Radiofrequency Ablation in Children
- ClinicalTrials.gov ID
- NCT00238823
- Acronym / sponsor ID
- 05-108
- Conditions
- Congenital Disorders
- Keywords
- cryoablation, radiofrequency ablation, pediatrics, cardiology
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 50 participants
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Dec 2004
- First posted
- 14 Oct 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.
The purpose of this retrospective study is to describe why and when we used cryo and why we crossed over when we used both RFA and cryo. It is also to determine if there is some predictor that would make us say one patient would be better served with one technique than another and to describe our overall acute success rate and then our 6-month recurrence rate with cryo ablation and compare it to our known success rate with RFA.
Detailed description
Cryotherapy (Cryo) is a new ablation energy source used instead of the radiofrequency (RFA) method for ablation of septal pathways. In the past year, we have used cryo approximately 50 times, however 50% of the cryo procedures crossed over from RFA to cryo or cryo to RFA. It appears to me that cryo use should be as an adjunct therapy to RFA instead of replacement of RFA.
I would like to describe why and when we used cryo and why we crossed over when we used both RFA and cryo. I would like to determine if there is some predictor that would make us say one patient would be better served with one technique than another. I would also describe our overall acute success rate and then our 6-month recurrence rate with cryo ablation and compare it to our known success rate with RFA. All of this can be done with a chart review.
This will be done through a retrospective study.
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- charts between January 1 and 2004 to December 31, 2004
- pediatric population
- those who were ablated
Key exclusion criteria (1 listed)
- -
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. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2007.
Related trials for Congenital Disorders
Active, not recruiting
Measuring Impact of Computer Gaming on Arm Use in Rett Syndrome
Rett Syndrome
RecruitingObservational study
Feasibility Study of a Chatbot AI-Driven Preliminary Screening System for Hereditary Cancer Syndromes
Hereditary Cancer Syndromes
Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Huntington Disease, Sarcopenia
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Colon Adenocarcinoma, DNA Repair Disorder
Not yet recruitingPhase 2
Combination of Avutometinib and Defactinib for Treatment of Relapsed, Refractory, Metastatic, or Unresectable Malignant Peripheral Nerve Sheath Tumor
MPNST (Malignant Peripheral Nerve Sheath Tumor)
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.
Margaret Strieper, DO principal investigator
Sibley Heart Center
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 3 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 23 May 2007. 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. 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 23 May 2007.