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

• Sponsor: Vivek Reddy (Other)
• Overall Status: Completed
• CT.gov ID: NCT01014741
• Collaborator: Abbott Medical Devices (Industry)
• Enrollment: 200
• Locations: 7
• Arms: 2
• Duration (Months): 63
• Patients Per Site: 28.6
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Persistent Atrial Fibrillation	Drug: Ibutilide; Drug: Placebo	N/A

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 Design

• Study Type: Interventional
• 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: Oct 1, 2009
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With 1 Year Freedom From AF / AT [one year]

   Freedom from atrial arrhythmia after repeat procedures with or without drugs

Secondary Outcome Measures

1. Procedure Time [at time of the procedure]

   Overall procedure duration

2. AF Termination [at time of the procedure]

   AF termination with complex fractionated atrial electrograms (CFAE) ablation

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regional Cardiology Associates	Sacramento	California	United States	95823
2	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
3	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
4	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
5	University Of Virginia Health System	Charlottesville	Virginia	United States	22908
6	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5
7	Republic of Korea University Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Vivek Reddy
• Abbott Medical Devices

Investigators

• Principal Investigator: Vivek Y Reddy, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vivek Reddy, Director Cardiac Arrhythmia Service, Professor Of Medicine, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT01014741
• Other Study ID Numbers: GCO 09-0906
• First Posted: Nov 17, 2009
• Last Update Posted: Feb 14, 2018
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Vivek Reddy, Director Cardiac Arrhythmia Service, Professor Of Medicine, Icahn School of Medicine at Mount Sinai: Atrial Fibrillation; Catheter Ablation; Complex Fractionate Electrograms
• Additional relevant MeSH terms: Atrial Fibrillation; Ibutilide

Study Results

Participant Flow

Arm/Group Title	Ibutilide Arm	Placebo Arm
Arm/Group Description	Ibutilide: 0.25mg IV ibutilide after pulmonary vein isolation (PVI) isolation prior to complex fractionated atrial electrograms (CFAE) ablation	Placebo: Placebo after PVI isolation prior to CFAE ablation.
Period Title: Overall Study
STARTED	105	95
COMPLETED	94	90
NOT COMPLETED	11	5

Baseline Characteristics

Arm/Group Title	Ibutilide Arm	Placebo Arm	Total
Arm/Group Description	Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.	Placebo: Placebo after PVI isolation prior to CFAE ablation.	Total of all reporting groups
Overall Participants	105	95	200
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60 (12)	60 (9)	60 (10.5)
Sex: Female, Male (Count of Participants)
Female	21 20%	23 24.2%	44 22%
Male	84 80%	72 75.8%	156 78%
Ejection Fraction (percent) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent]	54 (8)	55 (8)	54.5 (8)
Left atrial diameter (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	47 (7)	46 (8)	46.5 (7.5)
Hypertension (participants) [Number]
yes	58 55.2%	58 61.1%	116 58%
no	47 44.8%	37 38.9%	84 42%
Diabetes (participants) [Number]
yes	15 14.3%	17 17.9%	32 16%
no	90 85.7%	78 82.1%	168 84%
Coronary artery disease (participants) [Number]
yes	20 19%	10 10.5%	30 15%
no	85 81%	85 89.5%	170 85%
Stroke or transient ischaemic attack (participants) [Number]
yes	5 4.8%	6 6.3%	11 5.5%
no	100 95.2%	89 93.7%	189 94.5%
Congestive heart failure (participants) [Number]
yes	16 15.2%	7 7.4%	23 11.5%
no	89 84.8%	88 92.6%	177 88.5%
CHA2DS2VASc score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.6 (1.3)	1.4 (1.3)	1.5 (1.3)
Duration of current AF episode (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	9 (21)	10 (22)	9.5 (21.5)
Duration of longest AF episode (month) [Median (Standard Deviation) ]
Median (Standard Deviation) [month]	11 (22)	12 (23)	11.5 (22.5)
Long-lasting AF (participants) [Number]
yes	16 15.2%	22 23.2%	38 19%
no	89 84.8%	73 76.8%	162 81%
Prior hospitalization for AF (participants) [Number]
yes	34 32.4%	32 33.7%	66 33%
no	71 67.6%	63 66.3%	134 67%
Prior cardioversion (participants) [Number]
yes	84 80%	71 74.7%	155 77.5%
no	21 20%	24 25.3%	45 22.5%
Statin use (participants) [Number]
yes	35 33.3%	37 38.9%	72 36%
no	70 66.7%	58 61.1%	128 64%
ACE inhibitor/ARB use (participants) [Number]
yes	41 39%	39 41.1%	80 40%
no	64 61%	56 58.9%	120 60%
Current B-blocker use (participants) [Number]
yes	60 57.1%	50 52.6%	110 55%
no	45 42.9%	45 47.4%	90 45%
Current anti-arrhythmic drug use (participants) [Number]
yes	39 37.1%	35 36.8%	74 37%
no	66 62.9%	60 63.2%	126 63%
Prior anti-arrhythmic drug use (participants) [Number]
yes	37 35.2%	36 37.9%	73 36.5%
no	68 64.8%	59 62.1%	127 63.5%
Current amiodarone use (participants) [Number]
yes	6 5.7%	10 10.5%	16 8%
no	99 94.3%	85 89.5%	184 92%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Ninety-two patients in the ibutilide group and 93 patients in the placebo group remained in AF after study drug administration and underwent CFAE ablation.

Arm/Group Title	Ibutilide Arm	Placebo Arm
Arm/Group Description	Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.	Placebo: Placebo after PVI isolation prior to CFAE ablation.
Measure Participants	92	93
yes	65 61.9%	62 65.3%
no	27 25.7%	31 32.6%

2. Secondary Outcome

Title	Procedure Time
Description	Overall procedure duration
Time Frame	at time of the procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ibutilide Arm	Placebo Arm
Arm/Group Description	Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.	Placebo: Placebo after PVI isolation prior to CFAE ablation.
Measure Participants	105	95
Mean (Standard Deviation) [minutes]	316 (79)	321 (81)

3. Secondary Outcome

Title	AF Termination
Description	AF termination with complex fractionated atrial electrograms (CFAE) ablation
Time Frame	at time of the procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ibutilide Arm	Placebo Arm
Arm/Group Description	Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.	Placebo: Placebo after PVI isolation prior to CFAE ablation.
Measure Participants	105	95
yes	66 62.9%	52 54.7%
no	39 37.1%	43 45.3%

4. Secondary Outcome

Title	Radiofrequency Ablation Time
Time Frame	at time of the procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ibutilide Arm	Placebo Arm
Arm/Group Description	Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.	Placebo: Placebo after PVI isolation prior to CFAE ablation.
Measure Participants	105	95
Mean (Standard Deviation) [minutes]	99 (37)	104 (42)

Adverse Events

Arm/Group Title	Ibutilide Arm		Placebo Arm
Arm/Group Description	Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.		Placebo: Placebo after PVI isolation prior to CFAE ablation.
All Cause Mortality
	Ibutilide Arm		Placebo Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/94 (0%)		0/90 (0%)
Serious Adverse Events
	Ibutilide Arm		Placebo Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/94 (0%)		0/90 (0%)
Other (Not Including Serious) Adverse Events
	Ibutilide Arm		Placebo Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/94 (0%)		0/90 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.