Prophylactic Pulmonary Vein Isolation Study

Study Overview
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Brief Summary
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This study is being done to learn the effects of the Pulmonary Vein Isolation in patients that are at high risk to developing, but do not have a documented history of atrial fibrillation.

Detailed Description
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Patients with a dilated left atrium (left upper chamber of the heart) that undergo mitral valve surgery may be at risk for the development of atrial fibrillation after surgery. 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.

Official Title
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A Randomized, Single-blind Prophylactic Pulmonary Vein Isolation Procedure Utilizing Bipolar Radiofrequency Ablation in Patients Undergoing Mitral Valve Surgery

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Pulmonary Vein Isolation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for open-heart surgery: Mitral valve repair or replacement, evidence of a dilated left atrium Exclusion Criteria: History of Atrial Fibrillation 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation. | Procedure: Pulmonary Vein Isolation<br>* 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.<br>|
| No Intervention: 2<br>The control group of patients will undergo operation for mitral valve disease without the additional Pulmonary Vein Isolation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluated by the number of patients free of taking antiarrhythmic medications and free of AF as determined by a 24-hour Holter recording. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, AF, A fib, cardiac ablation, modified maze procedure