Ibutilide Administration During Pulmonary Vein Ablation (IBAD-AFIB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Ball Memorial Hospital
Sponsor:
Collaborator:
St. Jude Medical
Information provided by:
Ball Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00589992
First received: December 26, 2007
Last updated: January 27, 2012
Last verified: January 2012

December 26, 2007
January 27, 2012
October 2007
December 2015   (final data collection date for primary outcome measure)
To discern the basic mechanism of Afib by studying its response to Ibutilide administration. [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00589992 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Ibutilide Administration During Pulmonary Vein Ablation
Atrial Fibrillation Mechanism Analysis Through Ibutilide Administration During Pulmonary Vein Ablation.

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Atrial Fibrillation
  • Pulmonary Vein Ablation
Drug: Ibutilide fumarate
During scheduled radio frequency ablation for atrial fibrillation patients will be infused with 1mg of ibutilide over 10 minutes.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Antonio Navarrete, MD 765-281-2000 annavarr@mac.com
Contact: Sherry Adair, RN 765-254-4761 skadair@medicalconsultantspc.com
United States
 
NCT00589992
BMH study #762
No
Antonio Navarrete, MD, Medical Consultants, P.C.
Ball Memorial Hospital
St. Jude Medical
Principal Investigator: Antonio Navarrete, MD Staff Physician, Ball Memorial Hospital
Ball Memorial Hospital
January 2012

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