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

Not Applicable

Terminated

Interventions: Device: CardioInsight ECGI Mapping System
Procedure: AF ablation
Drug: Ibutilide

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

Detailed Description: This prospective, multicenter observational study will examine the ability of ECGi mapping to

1. Effect of Ibutilide on the number and size of the driver domains

2. Effect of ablation of Ibutilide-organized driver domains

3. Effect of PV isolation on driver domains

The researchers hypothesize that this approach will lead to successful arrhythmia control .

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Patients with AF	CardioInsight ECGI Mapping System	Patients with AF and planned to undergo first catheter procedure
Patients with AF	AF ablation	Patients with AF and planned to undergo first catheter procedure
Patients with AF	Ibutilide	Patients with AF and planned to undergo first catheter procedure

Primary Outcome Measures

Name	Time	Method
Number of Participants Who no Longer Has Recurrent At/AF	at 12 months	Freedom from recurrent At/AF

Secondary Outcome Measures

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