Ibutilide Administration During Pulmonary Vein Ablation

Condition(s) targeted: Atrial Fibrillation; Pulmonary Vein Ablation

Intervention: Ibutilide fumarate (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Ball Memorial Hospital

Official(s) and/or principal investigator(s):
Antonio Navarrete, MD, Principal Investigator, Affiliation: Staff Physician, Ball Memorial Hospital

Overall contact:
Antonio Navarrete, MD, Phone: 765-281-2000, Email: annavarr@mac.com

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

Study design: Basic Science, Open Label, Single Group Assignment

Primary outcome: To discern the basic mechanism of Afib by studying its response to Ibutilide administration.

Secondary outcome:

To compare the ibutilide response in patients with paroxysmal versus permanent Afib

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.

To improve the current results of pulmonary vein isolation by performing a procedure guided by ablation of high dominant frequency areas.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Antonio Navarrete, MD, Phone: 765-281-2000, Email: annavarr@mac.com

Ball Memorial Hospital, Muncie, Indiana 47303, United States; Recruiting
Julie Foster, RN, Phone: 765-747-8457, Email: JFoster@chsmail.org
Antonio Navarrete, MD, Principal Investigator

Starting date: October 2007
Ending date: December 2009
Last updated: December 26, 2007