Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2015-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ibutilide Administration During Pulmonary Vein Ablation

NCT00589992

Atrial Fibrillation Pulmonary Vein Ablation

UNKNOWN NA

STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation

NCT03118518

Atrial Fibrillation Atrial Fibrillation New Onset

COMPLETED NA

Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD

NCT00729911

Heart Failure

COMPLETED PHASE4

Therapy of Atrial Flutter by Afib Ablation

NCT02051621

Atrial Fibrillation Atrial Flutter

UNKNOWN NA

Cryoballoon Ablation as First Line Treatment of Atrial Flutter

NCT03401099

Atrial Flutter Typical

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Persistent Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ibutilide arm

Group Type EXPERIMENTAL

Ibutilide

Intervention Type DRUG

0.25mg IV ibutilide after PV isolation prior to CFE ablation

Placebo arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo after PV isolation prior to CFE ablation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ibutilide

0.25mg IV ibutilide after PV isolation prior to CFE ablation

Intervention Type DRUG

Placebo

Placebo after PV isolation prior to CFE ablation.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No