Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation
| Status: | Completed |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/16/2018 |
| Start Date: | October 2009 |
| End Date: | January 2015 |
Modified Stepwise Ablation Guided by Low Dose Ibutilide in Chronic Atrial Fibrillation
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.
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.
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.
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 β-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
We found this trial at
6
sites
Click here to add this to my saved trials
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
Click here to add this to my saved trials
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
Click here to add this to my saved trials
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials