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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03370536
Recruitment Status : Terminated (1 patient enrolled (consented) but screen failed. Study stopped as unable to enroll.)
First Posted : December 12, 2017
Results First Posted : February 10, 2020
Last Update Posted : February 10, 2020
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Vivek Reddy, Icahn School of Medicine at Mount Sinai

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Persistent Atrial Fibrillation Device: CardioInsight ECGI Mapping System Procedure: AF ablation Drug: Ibutilide Not Applicable

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 .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Panoramic ECGi to Guide Ablation of Non-Paroxysmal AF: Effect of Ibutilide on AF Source Location and Organization
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : July 18, 2018
Actual Study Completion Date : July 18, 2018

Resource links provided by the National Library of Medicine


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 Name: 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)




Primary Outcome Measures :
  1. Number of Participants Who no Longer Has Recurrent At/AF [ Time Frame: at 12 months ]
    Freedom from recurrent At/AF


Secondary Outcome Measures :
  1. Number of Drivers [ Time Frame: Baseline ]
    Number of drivers identified

  2. Size of Drivers [ Time Frame: Baseline ]
    Size of drivers ablated

  3. Percent Change of Driver Regions [ Time Frame: Baseline and 1 year ]
    Percent change of driver regions after ibutilide

  4. AF Termination Rate [ Time Frame: 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)

  5. Total Procedure Time [ Time Frame: within 24 hours after the procedure is completed the time is calculated ]
    Total duration of RF ablation/fluoroscopy time/exposure procedure time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370536


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Vivek Reddy
Medtronic
Investigators
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Principal Investigator: Jacob Koruth, MD Icahn School of Medicine at Mount Sinai
Study Chair: Vivek Reddy, MD Icahn School of Medicine at Mount Sinai
  Study Documents (Full-Text)

Documents provided by Vivek Reddy, Icahn School of Medicine at Mount Sinai:
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Responsible Party: Vivek Reddy, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03370536    
Other Study ID Numbers: GCO 40-5004
First Posted: December 12, 2017    Key Record Dates
Results First Posted: February 10, 2020
Last Update Posted: February 10, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Vivek Reddy, Icahn School of Medicine at Mount Sinai:
Atrial Fibrillation
Persistent Atrial Fibrillation
AFIB
Arrhythmia
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Ibutilide
Anti-Arrhythmia Agents