Trial | NCT00589992  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    ibutilide ...

  • Study Participants

    50
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.
Study Started
Oct 31
2007
Primary Completion
Dec 31
2015
Anticipated
Study Completion
Dec 31
2016
Anticipated
Last Update
Jan 31
2012
Estimate

Drug Ibutilide fumarate

During scheduled radio frequency ablation for atrial fibrillation patients will be infused with 1mg of ibutilide over 10 minutes.

Criteria 

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
No Results Posted