ECGi Ibutilide: Effect of Ibutilide on AF Source Location and Organization

Study Overview
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Brief Summary
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This is a prospective, multi-center, non-randomized, un-blinded, observational trial.

Detailed Description
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This prospective, multicenter observational study will examine the ability of ECGi mapping to Effect of Ibutilide on the number and size of the driver domains Effect of ablation of Ibutilide-organized driver domains Effect of PV isolation on driver domains The researchers hypothesize that this approach will lead to successful arrhythmia control .

Official Title
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Panoramic ECGi to Guide Ablation of Non-Paroxysmal AF: Effect of Ibutilide on AF Source Location and Organization

Conditions
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Atrial Fibrillation, Persistent Atrial Fibrillation

Intervention / Treatment
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* Device: CardioInsight ECGI Mapping System
* Procedure: AF ablation
* Drug: Ibutilide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age. ° Symptomatic persistent AF refractory or intolerant to at least 1 class I or III antiarrhythmic medication Persistent AF - defined as Persistent: AF that is sustained > 7 days. Episodes of AF which are terminated by electrical or pharmacologic cardioversion after ≥ 48 hours of AF, but prior to 7 days, should also be classified as persistent AF episodes. Planned to undergo first catheter ablation procedure ( prior atrial flutter typical is allowed) Ability to understand the requirements of the study and sign the informed consent form. Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements Projected lifespan greater than 1 year Exclusion Criteria: They have baseline prolonged QT or renal failure precluding safe used of ibutilide Rheumatic heart disease, Current intra-cardiac thrombus, History of MI or CABG within 6 weeks; Class IV HF, Unable to sign consent Projected lifespan of < 1 year Women known to be pregnant or to have positive beta-HCG. Participation in another study that would interfere with this study. Unstable Angina Recent cerebral ischemic events Contraindication to anticoagulation Prior history of polymorphic ventricular tachycardia or torsades de pointes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with AF<br>Patients with AF and planned to undergo first catheter procedure | Device: CardioInsight ECGI Mapping System<br>* The CardioInsight mapping system is a noninvasive, single beat cardiac arrhythmia mapping system that provides 3D electroanatomic maps of the heart.<br>* Other names: ECGi mapping;Procedure: AF ablation<br>* Empiric ablation (CFAE or linear ablation) is not permitted<br>* Other names: Biosense Smart Touch SF (STSF);Drug: Ibutilide<br>* Progressive doses of Ibutilide administered (0.25mg, then 0.25mg, then 0.5mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who no Longer Has Recurrent At/AF | Freedom from recurrent At/AF | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Drivers | Number of drivers identified | Baseline | 
| Size of Drivers | Size of drivers ablated | Baseline | 
| Percent Change of Driver Regions | Percent change of driver regions after ibutilide | Baseline and 1 year | 
| AF Termination Rate | AF termination rate is defined as AF termination to AT/SR (Atrial Tachycardia/Sinus Rhythm) | post ablation inducibility of AF after 5 minutes of burst pacing | 
| Total Procedure Time | Total duration of RF ablation/fluoroscopy time/exposure procedure time | within 24 hours after the procedure is completed the time is calculated | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Persistent Atrial Fibrillation, AFIB, Arrhythmia