Clinical trial NCT01014741: Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation
Official title: Modified Stepwise Ablation Guided by Low Dose Ibutilide in Chronic Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: Atrial Fibrillation
Catheter Ablation
Complex Fractionate Electrograms
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2009-11-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With 1 Year Freedom From AF / AT
timeFrame: one year
Secondary outcomes:
measure: Procedure Time
timeFrame: at time of the procedure
measure: AF Termination
timeFrame: at time of the procedure
measure: Radiofrequency Ablation Time
timeFrame: at time of the procedure
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Regional Cardiology Associates
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Charlottesville
country: United States
facility: University Of Virginia Health System
state: Virginia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Seoul
country: Korea, Republic of
facility: Republic of Korea University Medical Center
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Vivek Y Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.