IBAD-AFIB: Ibutilide Administration During Pulmonary Vein Ablation

• Sponsor: Ball Memorial Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00589992
• Collaborator: Abbott Medical Devices (Industry)
• Enrollment: 50
• Location: 1
• Duration (Months): 110
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation; Pulmonary Vein Ablation	Drug: Ibutilide fumarate	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Atrial Fibrillation Mechanism Analysis Through Ibutilide Administration During Pulmonary Vein Ablation.
• Study Start Date: Oct 1, 2007
• Anticipated Primary Completion Date: Dec 1, 2015
• Anticipated Study Completion Date: Dec 1, 2016

Outcome Measures

Primary Outcome Measures

1. To discern the basic mechanism of Afib by studying its response to Ibutilide administration. [one year]

Secondary Outcome Measures

1. To compare the ibutilide response in patients with paroxysmal versus permanent Afib [one year]

2. 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]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Consultants, P.C.	Muncie	Indiana	United States	47303

Sponsors and Collaborators

• Ball Memorial Hospital
• Abbott Medical Devices

Investigators

• Principal Investigator: Antonio Navarrete, MD, Staff Physician, Ball Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00589992
• Other Study ID Numbers: BMH study #762
• First Posted: Jan 10, 2008
• Last Update Posted: Jan 31, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Atrial Fibrillation; Ibutilide

Study Results

No Results Posted as of Jan 31, 2012