Clinical trial NCT03370536: ECGi Ibutilide: Effect of Ibutilide on AF Source Location and Organization
Official title: Panoramic ECGi to Guide Ablation of Non-Paroxysmal AF: Effect of Ibutilide on AF Source Location and Organization
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Persistent Atrial Fibrillation
Keywords: Atrial Fibrillation
Persistent Atrial Fibrillation
AFIB
Arrhythmia
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2017-12-12
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who no Longer Has Recurrent At/AF
timeFrame: at 12 months
Secondary outcomes:
measure: Number of Drivers
timeFrame: Baseline
measure: Size of Drivers
timeFrame: Baseline
measure: Percent Change of Driver Regions
timeFrame: Baseline and 1 year
measure: AF Termination Rate
timeFrame: post ablation inducibility of AF after 5 minutes of burst pacing
measure: Total Procedure Time
timeFrame: within 24 hours after the procedure is completed the time is calculated
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Jacob Koruth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Vivek Reddy, MD
role: STUDY_CHAIR
References: