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

This study has been completed.
Sponsor:
Collaborator:
St. Jude Medical
Information provided by (Responsible Party):
Vivek Reddy, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT01014741
First received: November 16, 2009
Last updated: April 17, 2017
Last verified: April 2017
Results First Received: April 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Persistent Atrial Fibrillation
Interventions: Drug: Ibutilide
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ibutilide Arm Ibutilide: 0.25mg IV ibutilide after pulmonary vein isolation (PVI) isolation prior to complex fractionated atrial electrograms (CFAE) ablation
Placebo Arm Placebo: Placebo after PVI isolation prior to CFAE ablation.

Participant Flow:   Overall Study
    Ibutilide Arm   Placebo Arm
STARTED   105   95 
COMPLETED   94   90 
NOT COMPLETED   11   5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Eligible patients were 18 years of age or older undergoing a first-ever catheter ablation procedure for persistent AF (i.e. continuous AF for at least 7 days; patients with at least 1 year of continuous AF were classified as long-standing persistent AF).

Reporting Groups
  Description
Ibutilide Arm Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
Placebo Arm Placebo: Placebo after PVI isolation prior to CFAE ablation.
Total Total of all reporting groups

Baseline Measures
   Ibutilide Arm   Placebo Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 105   95   200 
Age 
[Units: Years]
Mean (Standard Deviation)
 60  (12)   60  (9)   60  (10.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      21  20.0%      23  24.2%      44  22.0% 
Male      84  80.0%      72  75.8%      156  78.0% 
Ejection Fraction 
[Units: Percent]
Mean (Standard Deviation)
 54  (8)   55  (8)   54.5  (8) 
Left atrial diameter 
[Units: Mm]
Mean (Standard Deviation)
 47  (7)   46  (8)   46.5  (7.5) 
Hypertension 
[Units: Participants]
     
yes   58   58   116 
no   47   37   84 
Diabetes 
[Units: Participants]
     
yes   15   17   32 
no   90   78   168 
Coronary artery disease 
[Units: Participants]
     
yes   20   10   30 
no   85   85   170 
Stroke or transient ischaemic attack 
[Units: Participants]
     
yes   5   6   11 
no   100   89   189 
Congestive heart failure 
[Units: Participants]
     
yes   16   7   23 
no   89   88   177 
CHA2DS2VASc score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.6  (1.3)   1.4  (1.3)   1.5  (1.3) 
[1] CHA2DS2VASc Score calculates stroke risk for patients with atrial fibrillation. As CHA2DS2-VASc score increased, rate of thromboembolic event (TE) within 1 year in non-anticoagulated patients with non-valvular AF increased as well. Score of 0 to be low risk for TE events (none seen in cohort at one year), score of 1 intermediate risk (0.6% rate at 1 year), and greater than 1 high risk (3% rate at 1 year).
Duration of current AF episode 
[Units: Months]
Mean (Standard Deviation)
 9  (21)   10  (22)   9.5  (21.5) 
Duration of longest AF episode 
[Units: Month]
Median (Standard Deviation)
 11  (22)   12  (23)   11.5  (22.5) 
Long-lasting AF 
[Units: Participants]
     
yes   16   22   38 
no   89   73   162 
Prior hospitalization for AF 
[Units: Participants]
     
yes   34   32   66 
no   71   63   134 
Prior cardioversion 
[Units: Participants]
     
yes   84   71   155 
no   21   24   45 
Statin use 
[Units: Participants]
     
yes   35   37   72 
no   70   58   128 
ACE inhibitor/ARB use [1] 
[Units: Participants]
     
yes   41   39   80 
no   64   56   120 
[1] ACE, angiotensin-converting enzyme; ARB, angiotensin receptor blocker.
Current B-blocker use 
[Units: Participants]
     
yes   60   50   110 
no   45   45   90 
Current anti-arrhythmic drug use 
[Units: Participants]
     
yes   39   35   74 
no   66   60   126 
Prior anti-arrhythmic drug use 
[Units: Participants]
     
yes   37   36   73 
no   68   59   127 
Current amiodarone use 
[Units: Participants]
     
yes   6   10   16 
no   99   85   184 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   1 Year Freedom From AF / AT   [ Time Frame: one year ]

2.  Secondary:   Procedure Time   [ Time Frame: at time of the procedure ]

3.  Secondary:   AF Termination   [ Time Frame: at time of the procedure ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Vivek Reddy
Organization: Icahn School of Medicine at Mount Sinai
phone: 212-241-7114
e-mail: vivek.reddy@mountsinai.org


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Vivek Reddy, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01014741     History of Changes
Other Study ID Numbers: GCO 09-0906
Study First Received: November 16, 2009
Results First Received: April 17, 2017
Last Updated: April 17, 2017