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

Primary Purpose

Atrial Fibrillation, Persistent Atrial Fibrillation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CardioInsight ECGI Mapping System
AF ablation
Ibutilide
Sponsored by
Vivek Reddy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Persistent Atrial Fibrillation, AFIB, Arrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with AF

Arm Description

Patients with AF and planned to undergo first catheter procedure

Outcomes

Primary Outcome Measures

Number of Participants Who no Longer Has Recurrent At/AF
Freedom from recurrent At/AF

Secondary Outcome Measures

Number of Drivers
Number of drivers identified
Size of Drivers
Size of drivers ablated
Percent Change of Driver Regions
Percent change of driver regions after ibutilide
AF Termination Rate
AF termination rate is defined as AF termination to AT/SR (Atrial Tachycardia/Sinus Rhythm)
Total Procedure Time
Total duration of RF ablation/fluoroscopy time/exposure procedure time

Full Information

First Posted
December 4, 2017
Last Updated
January 28, 2020
Sponsor
Vivek Reddy
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT03370536
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
1 patient enrolled (consented) but screen failed. Study stopped as unable to enroll.
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
July 18, 2018 (Actual)
Study Completion Date
July 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vivek Reddy
Collaborators
Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Persistent Atrial Fibrillation
Keywords
Atrial Fibrillation, Persistent Atrial Fibrillation, AFIB, Arrhythmia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with AF
Arm Type
Experimental
Arm Description
Patients with AF and planned to undergo first catheter procedure
Intervention Type
Device
Intervention Name(s)
CardioInsight ECGI Mapping System
Other Intervention Name(s)
ECGi mapping
Intervention Description
The CardioInsight mapping system is a noninvasive, single beat cardiac arrhythmia mapping system that provides 3D electroanatomic maps of the heart.
Intervention Type
Procedure
Intervention Name(s)
AF ablation
Other Intervention Name(s)
Biosense Thermocool SF, Biosense Smart Touch SF (STSF)
Intervention Description
Empiric ablation (CFAE or linear ablation) is not permitted
Intervention Type
Drug
Intervention Name(s)
Ibutilide
Intervention Description
Progressive doses of Ibutilide administered (0.25mg, then 0.25mg, then 0.5mg)
Primary Outcome Measure Information:
Title
Number of Participants Who no Longer Has Recurrent At/AF
Description
Freedom from recurrent At/AF
Time Frame
at 12 months
Secondary Outcome Measure Information:
Title
Number of Drivers
Description
Number of drivers identified
Time Frame
Baseline
Title
Size of Drivers
Description
Size of drivers ablated
Time Frame
Baseline
Title
Percent Change of Driver Regions
Description
Percent change of driver regions after ibutilide
Time Frame
Baseline and 1 year
Title
AF Termination Rate
Description
AF termination rate is defined as AF termination to AT/SR (Atrial Tachycardia/Sinus Rhythm)
Time Frame
post ablation inducibility of AF after 5 minutes of burst pacing
Title
Total Procedure Time
Description
Total duration of RF ablation/fluoroscopy time/exposure procedure time
Time Frame
within 24 hours after the procedure is completed the time is calculated

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Koruth, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vivek Reddy, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Study Chair
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

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

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