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VT Ablation in the iCMR (VISABL-VT)

Primary Purpose

Ventricular Tachycardia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vision-MR Ablation Catheter 2.0
Sponsored by
Imricor Medical Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Tachycardia

Eligibility Criteria

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

Inclusion Criteria:

  • Documented (ECG/EGM) spontaneous episode of sustained ventricular tachycardia within 6 months
  • Diagnosis of Ischemic Cardiomyopathy
  • AAD therapy refractory, contraindicated, not tolerated, or not desired
  • 18 years or older

Exclusion Criteria:

  • Implanted with non-MR compatible medical devices or contraindicated for an MRI
  • Presence of intracardiac thrombus (verified via CT/MRI/echocardiogram within 48 hours of procedure - or at start of procedure)
  • Thrombocytopenia or coagulopathy
  • Mechanical mitral and/or aortic valve precluding access to the left ventricle
  • Severe aortic stenosis
  • Myocardial infarction requiring stent implantation within 90 days of procedure
  • Previous cardiac surgery within 60 days of procedures
  • Class IV Heart Failure
  • Ejection Fraction (EF) < 25%
  • Patients with a glomerular filtration rate (GFR) < 30
  • Women who are pregnant
  • Life expectancy < 12 months
  • Enrollment in another study without sponsor approval

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Non-Randomized

    Arm Description

    All subjects with ventricular tachycardia associated with ischemic cardiomyopathy will undergo catheter ablation using the Vision-MR Ablation Catheter 2.0

    Outcomes

    Primary Outcome Measures

    Primary Efficacy Endpoint
    Acute success defined as absence of inducible clinical ventricular tachycardia (VT) following the last RF application with with the investigational device.
    Primary Safety Endpoint
    Composite of any procedure or device related serious adverse events through 7 days post index ablation procedure

    Secondary Outcome Measures

    Secondary Efficacy Endpoint
    Chronic success defined as 6-month freedom from recurrence of sustained VT or VT requiring intervention and freedom from new or increased dose of Class I or III antiarrhythmic drugs (AAD) at 6 months following the index ablation procedure.

    Full Information

    First Posted
    September 14, 2022
    Last Updated
    September 18, 2022
    Sponsor
    Imricor Medical Systems
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05543798
    Brief Title
    VT Ablation in the iCMR
    Acronym
    VISABL-VT
    Official Title
    Vision-MR Ablation Catheter 2.0 for the Treatment of Ventricular Tachycardia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2022 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Imricor Medical Systems

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The VISABL-VT is a prospective, single-arm, multi-center, interventional investigation of the safety and efficacy of radiofrequency (RF) ablation of ventricular tachycardia associated with ischemic cardiomyopathy performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ventricular Tachycardia

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Non-Randomized
    Arm Type
    Experimental
    Arm Description
    All subjects with ventricular tachycardia associated with ischemic cardiomyopathy will undergo catheter ablation using the Vision-MR Ablation Catheter 2.0
    Intervention Type
    Device
    Intervention Name(s)
    Vision-MR Ablation Catheter 2.0
    Intervention Description
    Catheter ablation of ventricular tachycardia
    Primary Outcome Measure Information:
    Title
    Primary Efficacy Endpoint
    Description
    Acute success defined as absence of inducible clinical ventricular tachycardia (VT) following the last RF application with with the investigational device.
    Time Frame
    30 minutes post procedure
    Title
    Primary Safety Endpoint
    Description
    Composite of any procedure or device related serious adverse events through 7 days post index ablation procedure
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Secondary Efficacy Endpoint
    Description
    Chronic success defined as 6-month freedom from recurrence of sustained VT or VT requiring intervention and freedom from new or increased dose of Class I or III antiarrhythmic drugs (AAD) at 6 months following the index ablation procedure.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Documented (ECG/EGM) spontaneous episode of sustained ventricular tachycardia within 6 months Diagnosis of Ischemic Cardiomyopathy AAD therapy refractory, contraindicated, not tolerated, or not desired 18 years or older Exclusion Criteria: Implanted with non-MR compatible medical devices or contraindicated for an MRI Presence of intracardiac thrombus (verified via CT/MRI/echocardiogram within 48 hours of procedure - or at start of procedure) Thrombocytopenia or coagulopathy Mechanical mitral and/or aortic valve precluding access to the left ventricle Severe aortic stenosis Myocardial infarction requiring stent implantation within 90 days of procedure Previous cardiac surgery within 60 days of procedures Class IV Heart Failure Ejection Fraction (EF) < 25% Patients with a glomerular filtration rate (GFR) < 30 Women who are pregnant Life expectancy < 12 months Enrollment in another study without sponsor approval
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kate Lindborg, Phd
    Phone
    9528188400
    Email
    kate.lindborg@imricor.com

    12. IPD Sharing Statement

    Learn more about this trial

    VT Ablation in the iCMR

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