Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation

Persistent Atrial Fibrillation Clinical Trial

— MAGIC-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014741
• Other study ID #: GCO 09-0906
• Status: Completed
• Phase: N/A
• First received: November 16, 2009
• Last updated: January 17, 2018
• Start date: October 2009
• Est. completion date: January 2015

Study information

• Verified date: January 2018
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Drug:
• Ibutilide
0.25mg IV ibutilide after PV isolation prior to CFE ablation
• Placebo
Placebo after PV isolation prior to CFE ablation.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Vivek Reddy	St. Jude Medical

Countries where clinical trial is conducted

United States,  Canada,  Korea, Republic of, 

References & Publications (2)

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 — View 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 de — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With 1 Year Freedom From AF / AT	Freedom from atrial arrhythmia after repeat procedures with or without drugs	one year
Secondary	Procedure Time	Overall procedure duration	at time of the procedure
Secondary	AF Termination	AF termination with complex fractionated atrial electrograms (CFAE) ablation	at time of the procedure
Secondary	Radiofrequency Ablation Time		at time of the procedure