Ibutilide Administration During Pulmonary Vein Ablation

Not Applicable

• Conditions: Atrial Fibrillation; Pulmonary Vein Ablation

• Registration Number: NCT00589992
• Lead Sponsor: Ball Memorial Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2008-01-10
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-27
• Last Update Posted: 2012-01-31
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To discern the basic mechanism of Afib by studying its response to Ibutilide administration.	one year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical Consultants, P.C.; 🇺🇸 Muncie, Indiana, United States