NCT01014741

Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation

Modified Stepwise Ablation Guided by Low Dose Ibutilide in Chronic Atrial Fibrillation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Vivek Reddy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Ibutilide	0.25mg IV ibutilide after PV isolation prior to CFE ablation
DRUG	Placebo	Placebo after PV isolation prior to CFE ablation.

Timeline

• Start date: 2009-10-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2009-11-17
• Last updated: 2018-02-14
• Results posted: 2017-05-24

Locations

7 sites across 3 countries: United States, Canada, South Korea