Atrial Fibrillation, Pulmonary Vein Ablation
Conditions
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.
Interventions
DRUGIbutilide fumarate
During scheduled radio frequency ablation for atrial fibrillation patients will be infused with 1mg of ibutilide over 10 minutes.
Sponsors
Abbott Medical Devices
Ball Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To discern the basic mechanism of Afib by studying its response to Ibutilide administration. | one year |
Secondary
| Measure | 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 |
Countries
United States
Contacts
Primary ContactAntonio Navarrete, MD
Backup ContactSherry Adair, RN
Outcome results
None listed