Ibutilide Administration During Pulmonary Vein Ablation

Study Overview
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Brief Summary
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To test the hypothesis that localized functional reentry maintains Afib in humans, ibutilide will be administered intravenously in patients undergoing an Afib ablation. The hypothesis of this study is that ibutilide will decrease the high frequency signals observed in Afib suggesting the presence of micro reentrant circuits as the basic mechanism of Afib, especially for the paroxysmal Afib group. The potential difference in response to the ibutilide in patients with paroxysmal versus persistent Afib may show the difference in the underlying mechanism of Afib between these two groups.

Official Title
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Atrial Fibrillation Mechanism Analysis Through Ibutilide Administration During Pulmonary Vein Ablation.

Conditions
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Atrial Fibrillation, Pulmonary Vein Ablation

Intervention / Treatment
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* Drug: Ibutilide fumarate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients to be scheduled for atrial fibrillation radio frequency ablation paroxysmal, permanent symptomatic atrial fibrillation refractory to conventional treatment symptomatic atrial fibrillation that do not want or desire to take medication or undergo cardioversion patients on antiarrhythmics that can be discontinued 5 half lifes prior to the procedure except for Amiodarone Exclusion Criteria: patients with recent major hemorrhage (within 6 months) patients with a coagulopathy patients who are pregnant or breast feeding patients with acute congestive heart failure patients with hypokalemia or hyperkalemia patients with a prolonged QTc > 440mms patients with polymorphic ventricular tachycardia secondary to antiarrhythmic class III and class I patients with left ventricular dysfunction < 40% patients with a history of recent MI (< 1 month) patients with a history of an angioplasty of < 1 month patients with a history of coronary artery bypass grafting surgery of < 3 months. patients with a history of chronic renal failure or a creatinine clearance of < 30ml/m patients with a history of stroke of < 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ibutilide fumarate|During scheduled radio frequency ablation for atrial fibrillation patients will be infused with 1mg of ibutilide over 10 minutes.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To discern the basic mechanism of Afib by studying its response to Ibutilide administration. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the ibutilide response in patients with paroxysmal versus permanent Afib |  | one year | 
| To study the subgroup of patients that converted to sinus rhythm in order to identify various factors that may have increased their susceptibility to ibutilide. |  | one year | 
| To improve the current results of pulmonary vein isolation by performing a procedure guided by ablation of high dominant frequency areas. |  | One year |