Short Term Outcomes From Minimally Invasive Surgery for the Treatment of Atrial Fibrillation
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 10, 2007 | ||||||||
| Last Updated Date | June 3, 2008 | ||||||||
| Start Date ICMJE | March 2007 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Transtelephonic monitoring for the identification of post surgical Atrial Fibrillation [ Time Frame: six months and 1 year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00571597 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Short Term Outcomes From Minimally Invasive Surgery for the Treatment of Atrial Fibrillation | ||||||||
| Official Title ICMJE | Prospective Analysis of the Wolf Minimaze Procedure for Treatment of Atrial Fibrillation | ||||||||
| Brief Summary | The purpose of this study is to assess the efficacy of minimally invasive surgery for atrial fibrillation. |
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| Detailed Description | Patients who are undergoing or who have undergone minimally invasive surgery for atrial fibrillation will be followed prospectively. At 6 to 9 months, 1 and two years post surgery follow-up subjects will receive a trans-telephonic monitor to wear for approximately 1 month, and will submit transmissions on a daily basis. Episodes of atrial fibrillation will be documented during this time. The overall efficacy of the procedure will be assessed based on the freedom from atrial fibrillation at the time of transtelephonic monitoring. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Eligible subjects will be male or females age 18-85 that have elected to undergo or have undergone a minimally invasive "minimaze" surgery for the treatment of atrial firillation |
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| Condition ICMJE | Atrial Fibrillation | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 47 | ||||||||
| Estimated Completion Date | December 2008 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00571597 | ||||||||
| Other Study ID Numbers ICMJE | HM10695 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dr Kenneth Ellenbogen, MD, Virginia Commonwealth University | ||||||||
| Study Sponsor ICMJE | Virginia Commonwealth University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Virginia Commonwealth University | ||||||||
| Verification Date | June 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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