Persistent Atrial Fibrillation Clinical Trial
— MAGIC-AFOfficial title:
Modified Stepwise Ablation Guided by Low Dose Ibutilide in Chronic Atrial Fibrillation
Verified date | January 2018 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Vivek Reddy | St. Jude Medical |
United States, Canada, Korea, Republic of,
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
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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