Ibutilide Administration During Pulmonary Vein Ablation

Atrial Fibrillation Clinical Trial

— IBAD-AFIB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00589992
• Other study ID #: BMH study #762
• Status: Recruiting
• Phase: N/A
• First received: December 26, 2007
• Last updated: January 27, 2012
• Start date: October 2007
• Est. completion date: December 2016

Study information

• Verified date: January 2012
• Source: Ball Memorial Hospital
• Contact: Antonio Navarrete, MD
• Phone: 765-281-2000
• Email: annavarr[@]mac.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Atrial Fibrillation
• Pulmonary Vein Ablation

Intervention

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

Locations

Country	Name	City	State
United States	Medical Consultants, P.C.	Muncie	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Ball Memorial Hospital	St. Jude Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To discern the basic mechanism of Afib by studying its response to Ibutilide administration.		one year	No
Secondary	To compare the ibutilide response in patients with paroxysmal versus permanent Afib		one year	No
Secondary	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	No
Secondary	To improve the current results of pulmonary vein isolation by performing a procedure guided by ablation of high dominant frequency areas.		One year	No