- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00589992
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
Study Type
Interventional
Enrollment (Anticipated)
50
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 Contact
- Name: Antonio Navarrete, MD
- Phone Number: 765-281-2000
- Email: annavarr@mac.com
Study Contact Backup
- Name: Sherry Adair, RN
- Phone Number: 765-254-4761
- Email: skadair@medicalconsultantspc.com
Study Locations
-
-
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
No
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
Collaborators
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
December 26, 2007
First Posted (Estimate)
January 10, 2008
Study Record Updates
Last Update Posted (Estimate)
January 31, 2012
Last Update Submitted That Met QC Criteria
January 27, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BMH study #762
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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