Ibutilide Administration During Pulmonary Vein Ablation - Full Text View

Sponsor:	Ball Memorial Hospital
Collaborator:	St. Jude Medical
Information provided by:	Ball Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00589992

Purpose

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	Intervention
Atrial Fibrillation Pulmonary Vein Ablation	Drug: Ibutilide fumarate

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Atrial Fibrillation Mechanism Analysis Through Ibutilide Administration During Pulmonary Vein Ablation.

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Ibutilide Ibutilide Fumarate

U.S. FDA Resources

Further study details as provided by Ball Memorial Hospital:

Primary Outcome Measures:

To discern the basic mechanism of Afib by studying its response to Ibutilide administration. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	50
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Intervention Details:

During scheduled radio frequency ablation for atrial fibrillation patients will be infused with 1mg of ibutilide over 10 minutes.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

Responsible Party:	Antonio Navarrete, MD, Medical Consultants, P.C.
ClinicalTrials.gov Identifier:	NCT00589992 History of Changes
Other Study ID Numbers:	BMH study #762
Study First Received:	December 26, 2007
Last Updated:	January 27, 2012
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

Ibutilide
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012