Ibutilide Administration During Pulmonary Vein Ablation

NCT ID: NCT00589992

Last Updated: 2012-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2016-12-31

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.

Conditions

Atrial Fibrillation; Pulmonary Vein Ablation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Interventions

Ibutilide fumarate

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Ball Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Medical Consultants, P.C.

Principal Investigators

Antonio Navarrete, MD

Role: PRINCIPAL_INVESTIGATOR

Staff Physician, Ball Memorial Hospital

Locations

Medical Consultants, P.C.

Muncie, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Antonio Navarrete, MD

Role: CONTACT

annavarr@mac.com

765-281-2000

Sherry Adair, RN

Role: CONTACT

skadair@medicalconsultantspc.com

765-254-4761

Facility Contacts

Sherry Adair, RN

Role: primary

skadair@medicalconsultantspc.com

765-254-4761

Other Identifiers

BMH study #762

Identifier Type: -

Identifier Source: org_study_id