Ibutilide Administration During Pulmonary Vein Ablation (IBAD-AFIB)

January 27, 2012 updated by: Ball Memorial Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Drug: Ibutilide fumarate

Study Type

Interventional

Enrollment (Anticipated)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Indiana
  - Muncie, Indiana, United States, 47303
    - Recruiting
    - Medical Consultants, P.C.
    - Contact:
      
      Sherry Adair, RN
      
      Phone Number: 765-254-4761
      
      Email: skadair@medicalconsultantspc.com
    - Principal Investigator:
      
      Antonio Navarrete, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Basic Science
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To discern the basic mechanism of Afib by studying its response to Ibutilide administration. Time Frame: one year	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
To compare the ibutilide response in patients with paroxysmal versus permanent Afib Time Frame: one year	one year
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	one year
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	One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ball Memorial Hospital

Collaborators

Abbott Medical Devices

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria