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

January 17, 2018 updated by: Vivek Reddy

Modified Stepwise Ablation Guided by Low Dose Ibutilide in Chronic Atrial Fibrillation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Republic of Korea University Medical Center
  • United States
    • California
      • Sacramento, California, United States, 95823
        • Regional Cardiology Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo arm
Drug: Placebo
Placebo after PV isolation prior to CFE ablation.
Experimental: Ibutilide arm
Drug: Ibutilide
0.25mg IV ibutilide after PV isolation prior to CFE ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure Time
Time Frame: at time of the procedure
Overall procedure duration
at time of the procedure
AF Termination
Time Frame: at time of the procedure
AF termination with complex fractionated atrial electrograms (CFAE) ablation
at time of the procedure
Radiofrequency Ablation Time
Time Frame: at time of the procedure
at time of the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vivek Reddy

Collaborators

Abbott Medical Devices

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

November 16, 2009

First Submitted That Met QC Criteria

November 16, 2009

First Posted (Estimate)

November 17, 2009

Study Record Updates

Last Update Posted (Actual)

February 14, 2018

Last Update Submitted That Met QC Criteria

January 17, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 09-0906

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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