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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00238823
Other study ID # 05-108
Secondary ID
Status Terminated
Phase N/A
First received October 12, 2005
Last updated May 22, 2007
Start date January 2004
Est. completion date December 2004

Study information

Verified date May 2007
Source Children's Healthcare of Atlanta
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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 rate and then our 6-month recurrence rate with cryo ablation and compare it to our known success rate with RFA.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 50
Est. completion date December 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- charts between January 1 and 2004 to December 31, 2004

- pediatric population

- those who were ablated

Exclusion Criteria:

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal


Related Conditions & MeSH terms


Locations

Country Name City State
United States Children's Healthcare of Atlanta Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

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