Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation (MAGIC-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01014741
Recruitment Status : Completed
First Posted : November 17, 2009
Results First Posted : May 24, 2017
Last Update Posted : February 14, 2018
St. Jude Medical
Information provided by (Responsible Party):
Vivek Reddy, Icahn School of Medicine at Mount Sinai

Brief Summary:
Procedures for ablation of persistent or long lasting atrial fibrillation are frequently long and require extensive ablation. Some electrophysiologists administer the drug ibutilide during these procedures to help organize the fibrillatory activity of the left atrium with the hope that this may shorten the length of the procedure and duration of ablation needed. Currently there is no standardized approach of administering the drug ibutilide during these procedures, thus the investigators cannot be certain that administering this drug does in fact facilitate the procedure. The aim of the MAGIC-AF Trial is to see if administering a standard dose of the drug ibutilide at a standard time in the procedure can allow for a reduction in the ablation procedure time. The investigators hypothesize that administering ibutilide during these procedures will result in a reduction in the procedure and ablation time required.

Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Drug: Ibutilide Drug: Placebo Not Applicable

Detailed Description:
Definition: Patients with persistent atrial fibrillation will be enrolled in this trial. All patients will be required to be in atrial fibrillation on the day of the procedure. Standard pulmonary vein (PV) isolation will be performed. Patients will be enrolled in the trial if they remain in atrial fibrillation after bi-directional block is obtained in the left and right sided PVs. At this point, patients will be randomized to receive 0.25mg of IV ibutilide or a placebo (normal saline). Patients will then undergo additional ablation with areas of complex fractionate electrograms (CFE) being targeted. The duration of additional CFE ablation and use of additional non-PV ablation (i.e. placement of linear lesions) will be left to the discretion of the operator. Patients will be followed for 1 year. The primary outcome assessed will be freedom from AF at 1 year.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Modified Stepwise Ablation Guided by Low Dose Ibutilide in Chronic Atrial Fibrillation
Study Start Date : October 2009
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ibutilide arm Drug: Ibutilide
0.25mg IV ibutilide after PV isolation prior to CFE ablation

Placebo Comparator: Placebo arm Drug: Placebo
Placebo after PV isolation prior to CFE ablation.

Primary Outcome Measures :
  1. Number of Participants With 1 Year Freedom From AF / AT [ Time Frame: one year ]
    Freedom from atrial arrhythmia after repeat procedures with or without drugs

Secondary Outcome Measures :
  1. Procedure Time [ Time Frame: at time of the procedure ]
    Overall procedure duration

  2. AF Termination [ Time Frame: at time of the procedure ]
    AF termination with complex fractionated atrial electrograms (CFAE) ablation

  3. Radiofrequency Ablation Time [ Time Frame: at time of the procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males and females will be enrolled in the study.
  • Age >18
  • Referred for a first ever ablation procedure for symptomatic persistent/permanent AF (only prior ablation of right-sided typical flutter is permitted)
  • All patients must understand the requirements of the study and be willing to comply with the post study follow-up requirements.
  • Patients must be in atrial fibrillation on the day of the procedure

Exclusion Criteria:

  • Any reversible cause of AF (post-surgery, thyroid disorder, etc.)
  • Patients with a myocardial infarction or unstable angina in the previous 2 months.
  • Patients with a history of rheumatic heart disease
  • Patients with congenital heart disease
  • Patients with a history of hypertrophic cardiomyopathy
  • Patients with LV ejection fraction < 35%
  • Class IV congestive heart failure
  • Patients who have experienced any cerebral ischemic event, including any TIA in the preceding 1 month.
  • Women who are known to be pregnant or have had a positive β-HCG test 7 days prior to procedure.
  • Patients with any other significant uncontrolled or unstable medical condition (including uncontrolled clinically significant coagulation disorders).
  • Patients whose life expectancy is less than one year.
  • History of malignant ventricular arrhythmias or long QT interval (>500msec)
  • Prior left-sided cardiac ablation procedure (catheter based or surgical)
  • Mental impairment precluding the patient from providing informed consent or completing the appropriate follow up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01014741

United States, California
Regional Cardiology Associates
Sacramento, California, United States, 95823
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, Virginia
University Of Virginia Health System
Charlottesville, Virginia, United States, 22908
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Korea, Republic of
Republic of Korea University Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Vivek Reddy
St. Jude Medical
Principal Investigator: Vivek Y Reddy, MD Icahn School of Medicine at Mount Sinai

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Vivek Reddy, Director Cardiac Arrhythmia Service, Professor Of Medicine, Icahn School of Medicine at Mount Sinai Identifier: NCT01014741     History of Changes
Other Study ID Numbers: GCO 09-0906
First Posted: November 17, 2009    Key Record Dates
Results First Posted: May 24, 2017
Last Update Posted: February 14, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Vivek Reddy, Icahn School of Medicine at Mount Sinai:
Atrial Fibrillation
Catheter Ablation
Complex Fractionate Electrograms

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents