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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
St. Jude Medical
Information provided by (Responsible Party):
Vivek Reddy, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01014741
First received: November 16, 2009
Last updated: March 23, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Persistent Atrial Fibrillation
 Drug: Ibutilide
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Modified Stepwise Ablation Guided by Low Dose Ibutilide in Chronic Atrial Fibrillation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 1 year freedom from AF / AT [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Procedure time [ Time Frame: at time of the procedure ] [ Designated as safety issue: No ]
  • Rate of acute intra-procedural termination of AF [ Time Frame: at time of the procedure ] [ Designated as safety issue: No ]
  • Radiofrequency ablation time [ Time Frame: at time of the procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014741

Locations
United States, California
Regional Cardiology Associates
Sacramento, California, United States
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
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
Investigators
Principal Investigator: Vivek Y Reddy, MD Icahn School of Medicine at Mount Sinai
  More Information

No publications provided by Mount Sinai School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Vivek Reddy, Director Cardiac Arrhythmia Service, Professor Of Medicine, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01014741     History of Changes
Other Study ID Numbers: GCO#09-0906
Study First Received: November 16, 2009
Last Updated: March 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Atrial Fibrillation
Catheter Ablation
Complex Fractionate Electrograms

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Ibutilide
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013