Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation
This study is currently recruiting participants.
Verified March 2013 by University of Florida
Sponsor:
University of Florida
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01442181
First received: October 5, 2010
Last updated: March 13, 2013
Last verified: March 2013
| Tracking Information | |||||
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| First Received Date ICMJE | October 5, 2010 | ||||
| Last Updated Date | March 13, 2013 | ||||
| Start Date ICMJE | March 2010 | ||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
Quality of life satisfaction between patients treated surgically or patients treated medically in stroke patients with atrial fibrillation [ Time Frame: 6 months ] [ Designated as safety issue: No ] Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF with validated metrics. |
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| Change History | Complete list of historical versions of study NCT01442181 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Comparison of Adverse Events between surgery and medical management patients [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: Yes ] Compare adverse events between surgery and medical management patients, recurrent stroke,TIAs, AF burden, repeat interventions, bleeding and surgical morbidity. Maintaining NSR and 6 months. |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation | ||||
| Official Title ICMJE | Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation | ||||
| Brief Summary | The purpose of this study is to compare a minimally invasive surgical procedure and medication management in stroke patients with Atrial Fibrillation. The two treatment options are a minimally invasive surgical procedure or the use of medications. |
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| Detailed Description | Must have had a stroke or transient ischemic attack (TIA) and have Atrial Fibrillation |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| 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 | 30 | ||||
| Estimated Completion Date | April 2013 | ||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01442181 | ||||
| Other Study ID Numbers ICMJE | 433-2009 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of Florida | ||||
| Study Sponsor ICMJE | University of Florida | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Florida | ||||
| Verification Date | March 2013 | ||||
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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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