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

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

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

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation; Persistent Atrial Fibrillation
• Intervention / Treatment: Device: CardioInsight ECGI Mapping System; Procedure: AF ablation; Drug: Ibutilide

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 .

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with AF; Patients with AF and planned to undergo first catheter procedure

Device: CardioInsight ECGI Mapping System; The CardioInsight mapping system is a noninvasive, single beat cardiac arrhythmia mapping system that provides 3D electroanatomic maps of the heart.; Other Names: ECGi mapping; Procedure: AF ablation; Empiric ablation (CFAE or linear ablation) is not permitted; Other Names: Biosense Thermocool SF; Biosense Smart Touch SF (STSF); Drug: Ibutilide; Progressive doses of Ibutilide administered (0.25mg, then 0.25mg, then 0.5mg)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vivek Reddy
• Collaborators: Medtronic
• Investigators: Principal Investigator: Jacob Koruth, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): July 18, 2018
• Study Completion (Actual): July 18, 2018

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): February 10, 2020
• Last Update Submitted That Met QC Criteria: January 28, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Arrhythmia; Persistent Atrial Fibrillation; AFIB
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Anti-Arrhythmia Agents; Ibutilide
• Other Study ID Numbers: GCO 40-5004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes