Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation

Completed · Not applicable · Has a placebo group

Conditions studied: Persistent Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT01014741

Run by

Vivek Reddy

People needed

200

Starts

2009-10-01

Expected to finish

2015-01-01

Last updated by the study team

2018-02-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Regional Cardiology Associates — Sacramento, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• University Of Virginia Health System — Charlottesville, Virginia, United States
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• Republic of Korea University Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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