Ibutilide Administration During Pulmonary Vein Ablation - Tabular View

Tracking Information

First Received Date ^ICMJE

December 26, 2007

Last Updated Date

January 29, 2009

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To discern the basic mechanism of Afib by studying its response to Ibutilide administration. [ Time Frame: one year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00589992 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To compare the ibutilide response in patients with paroxysmal versus permanent Afib [ Time Frame: one year ] [ Designated as safety issue: No ]
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. [ Time Frame: one year ] [ Designated as safety issue: No ]
To improve the current results of pulmonary vein isolation by performing a procedure guided by ablation of high dominant frequency areas. [ Time Frame: One year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Ibutilide Administration During Pulmonary Vein Ablation

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Basic Science, Open Label, Single Group Assignment

Condition ^ICMJE

Atrial Fibrillation
Pulmonary Vein Ablation

Intervention ^ICMJE

Drug: Ibutilide fumarate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2011

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Antonio Navarrete, MD	765-281-2000	annavarr@mac.com
Contact: Julie Foster, RN	765-747-8457	Jfoster@chsmail.org

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00589992

Responsible Party

Antonio Navarrete, MD, Medical Consultants, P.C.

Study ID Numbers ^ICMJE

BMH study #762

Study Sponsor ^ICMJE

Ball Memorial Hospital

Collaborators ^ICMJE

St. Jude Medical

Investigators ^ICMJE

Principal Investigator:

Antonio Navarrete, MD

Staff Physician, Ball Memorial Hospital

Information Provided By

Ball Memorial Hospital

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP