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

Primary Purpose

Persistent Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ibutilide
Placebo
Sponsored by
Vivek Reddy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Atrial Fibrillation, Catheter Ablation, Complex Fractionate Electrograms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regional Cardiology Associates
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Icahn School of Medicine at Mount Sinai
  • University Of Virginia Health System
  • Sunnybrook Health Sciences Centre
  • Republic of Korea University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ibutilide arm

Placebo arm

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With 1 Year Freedom From AF / AT
Freedom from atrial arrhythmia after repeat procedures with or without drugs

Secondary Outcome Measures

Procedure Time
Overall procedure duration
AF Termination
AF termination with complex fractionated atrial electrograms (CFAE) ablation
Radiofrequency Ablation Time

Full Information

First Posted
November 16, 2009
Last Updated
January 17, 2018
Sponsor
Vivek Reddy
Collaborators
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01014741
Brief Title
Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation
Acronym
MAGIC-AF
Official Title
Modified Stepwise Ablation Guided by Low Dose Ibutilide in Chronic Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vivek Reddy
Collaborators
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
Atrial Fibrillation, Catheter Ablation, Complex Fractionate Electrograms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibutilide arm
Arm Type
Experimental
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ibutilide
Intervention Description
0.25mg IV ibutilide after PV isolation prior to CFE ablation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo after PV isolation prior to CFE ablation.
Primary Outcome Measure Information:
Title
Number of Participants With 1 Year Freedom From AF / AT
Description
Freedom from atrial arrhythmia after repeat procedures with or without drugs
Time Frame
one year
Secondary Outcome Measure Information:
Title
Procedure Time
Description
Overall procedure duration
Time Frame
at time of the procedure
Title
AF Termination
Description
AF termination with complex fractionated atrial electrograms (CFAE) ablation
Time Frame
at time of the procedure
Title
Radiofrequency Ablation Time
Time Frame
at time of the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivek Y Reddy, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional Cardiology Associates
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University Of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Republic of Korea University Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26850076
Citation
Singh SM, d'Avila A, Kim YH, Aryana A, Mangrum JM, Michaud GF, Dukkipati SR, Barrett CD, Heist EK, Parides MK, Thorpe KE, Reddy VY. The modified stepwise ablation guided by low-dose ibutilide in chronic atrial fibrillation trial (The MAGIC-AF Study). Eur Heart J. 2016 May 21;37(20):1614-21. doi: 10.1093/eurheartj/ehw003. Epub 2016 Feb 4.
Results Reference
result
PubMed Identifier
22034996
Citation
Singh SM, D'Avila A, Kim YH, Aryana A, Mangrum JM, Michaud GF, Dukkipati SR, Callans DJ, Barrett CD, Beras-Jovine MR, Reddy VY. The Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation (MAGIC-AF) Study: clinical background and study design. J Cardiovasc Electrophysiol. 2012 Apr;23(4):352-8. doi: 10.1111/j.1540-8167.2011.02198.x. Epub 2011 Oct 28.
Results Reference
result
PubMed Identifier
27702847
Citation
Singh SM, d'Avila A, Kim YH, Aryana A, Mangrum JM, Michaud GF, Dukkipati SR, Barrett CD, Heist EK, Parides MK, Thorpe KE, Reddy VY. Termination of persistent atrial fibrillation during pulmonary vein isolation: insight from the MAGIC-AF trial. Europace. 2017 Oct 1;19(10):1657-1663. doi: 10.1093/europace/euw266.
Results Reference
derived

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Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation

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