Recruiting

Ibutilide

Sponsor:

Ball Memorial Hospital

Code:

NCT00589992

Conditions

Atrial Fibrillation

Pulmonary Vein Ablation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ibutilide fumarate

Study Details

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 ID

NCT00589992

Start date

Oct, 2007

Status verified date

Jan, 2012

Completion date

Dec, 2016

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Interventions

Ibutilide fumarate

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Antonio Navarrete, MD

765-281-2000annavarr@mac.com

Sherry Adair, RN

765-254-4761skadair@medicalconsultantspc.com

Locations

Medical Consultants, P.C.

Recruiting

Muncie, Indiana, United States, 47303

Contacts

Sherry Adair, RN

765-254-4761skadair@medicalconsultantspc.com

Principal Investigator:

Antonio Navarrete, MD

More Information

Sponsor

Ball Memorial Hospital

Last update posted

Jan 31, 2012

Last verified

Jan, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ball Memorial Hospital on 2012-01-31.