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Ibutilide Administration During Pulmonary Vein Ablation (IBAD-AFIB)

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ClinicalTrials.gov Identifier: NCT00589992
Recruitment Status : Unknown
Verified January 2012 by Ball Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : January 10, 2008
Last Update Posted : January 31, 2012
Sponsor:
Collaborator:
St. Jude Medical
Information provided by:
Ball Memorial Hospital

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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 : October 2007
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources


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


Primary Outcome Measures :
  1. To discern the basic mechanism of Afib by studying its response to Ibutilide administration. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. To compare the ibutilide response in patients with paroxysmal versus permanent Afib [ Time Frame: 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. [ Time Frame: one year ]
  3. 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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00589992


Contacts
Contact: Antonio Navarrete, MD 765-281-2000 annavarr@mac.com
Contact: Sherry Adair, RN 765-254-4761 skadair@medicalconsultantspc.com

Locations
United States, Indiana
Medical Consultants, P.C. Recruiting
Muncie, Indiana, United States, 47303
Contact: Sherry Adair, RN    765-254-4761    skadair@medicalconsultantspc.com   
Principal Investigator: Antonio Navarrete, MD         
Sponsors and Collaborators
Ball Memorial Hospital
St. Jude Medical
Investigators
Principal Investigator: Antonio Navarrete, MD Staff Physician, Ball Memorial Hospital

Responsible Party: Antonio Navarrete, MD, Medical Consultants, P.C.
ClinicalTrials.gov Identifier: NCT00589992     History of Changes
Other Study ID Numbers: BMH study #762
First Posted: January 10, 2008    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Ibutilide
Anti-Arrhythmia Agents