Ibutilide Administration During Pulmonary Vein Ablation

NCT00589992 | Unknown

• 1 other identifier: BMH study #762
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  one year

Secondary Outcomes (3)

• To compare the ibutilide response in patients with paroxysmal versus permanent Afib

  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.

  one year

• To improve the current results of pulmonary vein isolation by performing a procedure guided by ablation of high dominant frequency areas.

  One year

Interventions

Ibutilide fumarate DRUG

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ball Memorial Hospital: lead
• Abbott Medical Devices: collaborator

Study Sites (1)

Medical Consultants, P.C.

Muncie, Indiana, 47303, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

ibutilide

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonio Navarrete, MD

  Staff Physician, Ball Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Navarrete, MD

CONTACT

765-281-2000; annavarr@mac.com

Sherry Adair, RN

CONTACT

765-254-4761; skadair@medicalconsultantspc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 10, 2008
• Study Start: October 1, 2007
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: January 31, 2012

Record last verified: 2012-01

Locations

US (1)