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Ibutilide Administration During Pulmonary Vein Ablation (IBAD-AFIB)

Primary Purpose

Atrial Fibrillation, Pulmonary Vein Ablation

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ibutilide fumarate
Sponsored by
Ball Memorial Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Consultants, P.C.Recruiting

Outcomes

Primary Outcome Measures

To discern the basic mechanism of Afib by studying its response to Ibutilide administration.

Secondary Outcome Measures

To compare the ibutilide response in patients with paroxysmal versus permanent Afib
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.
To improve the current results of pulmonary vein isolation by performing a procedure guided by ablation of high dominant frequency areas.

Full Information

First Posted
December 26, 2007
Last Updated
January 27, 2012
Sponsor
Ball Memorial Hospital
Collaborators
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00589992
Brief Title
Ibutilide Administration During Pulmonary Vein Ablation
Acronym
IBAD-AFIB
Official Title
Atrial Fibrillation Mechanism Analysis Through Ibutilide Administration During Pulmonary Vein Ablation.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ball Memorial Hospital
Collaborators
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Pulmonary Vein Ablation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ibutilide fumarate
Intervention Description
During scheduled radio frequency ablation for atrial fibrillation patients will be infused with 1mg of ibutilide over 10 minutes.
Primary Outcome Measure Information:
Title
To discern the basic mechanism of Afib by studying its response to Ibutilide administration.
Time Frame
one year
Secondary Outcome Measure Information:
Title
To compare the ibutilide response in patients with paroxysmal versus permanent Afib
Time Frame
one year
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Navarrete, MD
Phone
765-281-2000
Email
annavarr@mac.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sherry Adair, RN
Phone
765-254-4761
Email
skadair@medicalconsultantspc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Navarrete, MD
Organizational Affiliation
Staff Physician, Ball Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Consultants, P.C.
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherry Adair, RN
Phone
765-254-4761
Email
skadair@medicalconsultantspc.com
First Name & Middle Initial & Last Name & Degree
Antonio Navarrete, MD

12. IPD Sharing Statement

Learn more about this trial

Ibutilide Administration During Pulmonary Vein Ablation

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