Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
41 participants
INTERVENTIONAL
2007-01-31
2009-11-30
Brief Summary
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Detailed Description
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Atrial fibrillation (also known as "A-Fib" or AF) is an abnormal heart rhythm which may cause symptoms such as pounding sensations in your chest, dizziness, fatigue, chest pain and/or shortness of breath. AF patients are at a higher risk of developing a stroke.
Participants who sign informed consent will be randomized into one of two groups by chance (as in the flip of a coin).
Approximately 77 patients will undergo their mitral valve operation along with Pulmonary Vein Isolation (a treatment group) and 77 patients who do not undergo Pulmonary Vein Isolation at the time of their mitral valve surgery (a control group).
The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation using a device that delivers radiofrequency energy to the heart muscle in order to create scar tissue to block electrical impulses that can trigger episodes of AF.
The control group of patients will undergo operation for mitral valve disease without the additional Pulmonary Vein Isolation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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1
The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation.
Pulmonary Vein Isolation
The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation using a device that delivers radiofrequency energy to the heart muscle in order to create scar tissue to block electrical impulses that can trigger episodes of AF.
2
The control group of patients will undergo operation for mitral valve disease without the additional Pulmonary Vein Isolation
No interventions assigned to this group
Interventions
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Pulmonary Vein Isolation
The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation using a device that delivers radiofrequency energy to the heart muscle in order to create scar tissue to block electrical impulses that can trigger episodes of AF.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Need for emergent cardiac surgery
* Previous cardiac surgery
* Preoperative need for an intraaortic balloon pump or intravenous inotropes
* Current diagnosis of active endocarditis
* Mental impairment/or experience other conditions which may not allow subject to understand nature
* Significance and scope of study
* Pregnancy
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Mayo Clinic
Principal Investigators
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Thoralf M. Sundt, III, M.D.
Role: PRINCIPAL_INVESTIGATOR
Professor of Surgery, Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Other Identifiers
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06-005543
Identifier Type: -
Identifier Source: org_study_id
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