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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibutilide arm | Experimental |
| |
| Placebo arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibutilide | Drug | 0.25mg IV ibutilide after PV isolation prior to CFE ablation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 1 Year Freedom From AF / AT | Freedom from atrial arrhythmia after repeat procedures with or without drugs | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Time | Overall procedure duration | at time of the procedure |
| AF Termination | AF termination with complex fractionated atrial electrograms (CFAE) ablation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivek Y Reddy, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Cardiology Associates | Sacramento | California | 95823 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26850076 | Result | 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 Heart J. 2016 May 21;37(20):1614-21. doi: 10.1093/eurheartj/ehw003. Epub 2016 Feb 4. | |
| 22034996 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibutilide Arm | Ibutilide: 0.25mg IV ibutilide after pulmonary vein isolation (PVI) isolation prior to complex fractionated atrial electrograms (CFAE) ablation |
| FG001 | Placebo Arm | Placebo: Placebo after PVI isolation prior to CFAE ablation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibutilide Arm | Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation. |
| BG001 | Placebo Arm | Placebo: Placebo after PVI isolation prior to CFAE ablation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With 1 Year Freedom From AF / AT | Freedom from atrial arrhythmia after repeat procedures with or without drugs | Ninety-two patients in the ibutilide group and 93 patients in the placebo group remained in AF after study drug administration and underwent CFAE ablation. | Posted | Number | participants | one year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibutilide Arm | Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vivek Reddy | Icahn School of Medicine at Mount Sinai | 212-241-7114 | vivek.reddy@mountsinai.org |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C067192 | ibutilide |
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| Placebo |
| Drug |
Placebo after PV isolation prior to CFE ablation. |
|
| at time of the procedure |
| Radiofrequency Ablation Time | at time of the procedure |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| University Of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Republic of Korea University Medical Center | Seoul | South Korea |
| 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 design. J Cardiovasc Electrophysiol. 2012 Apr;23(4):352-8. doi: 10.1111/j.1540-8167.2011.02198.x. Epub 2011 Oct 28. |
| 27702847 | Derived | 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. Termination of persistent atrial fibrillation during pulmonary vein isolation: insight from the MAGIC-AF trial. Europace. 2017 Oct 1;19(10):1657-1663. doi: 10.1093/europace/euw266. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ejection Fraction | Mean | Standard Deviation | percent |
|
| Left atrial diameter | Mean | Standard Deviation | mm |
|
| Hypertension | Number | participants |
|
| Diabetes | Number | participants |
|
| Coronary artery disease | Number | participants |
|
| Stroke or transient ischaemic attack | Number | participants |
|
| Congestive heart failure | Number | participants |
|
| CHA2DS2VASc score | CHA2DS2VASc Score calculates stroke risk for patients with atrial fibrillation. As CHA2DS2-VASc score increased, rate of thromboembolic event (TE) within 1 year in non-anticoagulated patients with non-valvular AF increased as well. Score of 0 to be low risk for TE events (none seen in cohort at one year), score of 1 intermediate risk (0.6% rate at 1 year), and greater than 1 high risk (3% rate at 1 year). | Mean | Standard Deviation | units on a scale |
|
| Duration of current AF episode | Mean | Standard Deviation | months |
|
| Duration of longest AF episode | Median | Standard Deviation | month |
|
| Long-lasting AF | Number | participants |
|
| Prior hospitalization for AF | Number | participants |
|
| Prior cardioversion | Number | participants |
|
| Statin use | Number | participants |
|
| ACE inhibitor/ARB use | ACE, angiotensin-converting enzyme; ARB, angiotensin receptor blocker. | Number | participants |
|
| Current B-blocker use | Number | participants |
|
| Current anti-arrhythmic drug use | Number | participants |
|
| Prior anti-arrhythmic drug use | Number | participants |
|
| Current amiodarone use | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Procedure Time | Overall procedure duration | Posted | Mean | Standard Deviation | minutes | at time of the procedure |
|
|
|
| Secondary | AF Termination | AF termination with complex fractionated atrial electrograms (CFAE) ablation | Posted | Number | participants | at time of the procedure |
|
|
|
| Secondary | Radiofrequency Ablation Time | Posted | Mean | Standard Deviation | minutes | at time of the procedure |
|
|
|
| 0 |
| 94 |
| 0 |
| 94 |
| 0 |
| 94 |
| EG001 | Placebo Arm | Placebo: Placebo after PVI isolation prior to CFAE ablation. | 0 | 90 | 0 | 90 | 0 | 90 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |