Clinical trial NCT00589992: Ibutilide Administration During Pulmonary Vein Ablation
Official title: Atrial Fibrillation Mechanism Analysis Through Ibutilide Administration During Pulmonary Vein Ablation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Pulmonary Vein Ablation
Lead sponsor: Ball Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2008-01-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: To discern the basic mechanism of Afib by studying its response to Ibutilide administration.
timeFrame: one year
Secondary outcomes:
measure: To compare the ibutilide response in patients with paroxysmal versus permanent Afib
timeFrame: one year
measure: 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.
timeFrame: one year
measure: To improve the current results of pulmonary vein isolation by performing a procedure guided by ablation of high dominant frequency areas.
timeFrame: One year
Other outcomes:
Locations:
city: Muncie
country: United States
facility: Medical Consultants, P.C.
state: Indiana
Study officials:
affiliation: Staff Physician, Ball Memorial Hospital
name: Antonio Navarrete, MD
role: PRINCIPAL_INVESTIGATOR
References: