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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01014741
Other study ID # GCO 09-0906
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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