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Atrial Flutter Ablation in the iCMR (VISABL-AFL)

Primary Purpose

Atrial Flutter Typical

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
RF Ablation
Sponsored by
Imricor Medical Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Flutter Typical focused on measuring RF Ablation, interventional Cardiac Magnetic Resonance (iCMR)

Eligibility Criteria

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

Inclusion Criteria: Patient indicated for type I atrial flutter ablations with at least 1 documented episode of type I atrial flutter within 6 months (180 days) of enrollment Patient 18 years and older Exclusion Criteria: Contraindications for MRI procedures Patients who cannot have anti-arrhythmic drugs (class I or class III) prescribed for the treatment of type I atrial flutter stopped on the day of the procedure Previous CTI ablation procedures Myocardial infarction within 60 days of enrollment Current unstable angina Cardiac surgery within 90 days of enrollment Any cerebral ischemic event (including transient ischemic attacks) within 6 months (180 days) of enrollment Thrombocytosis or thrombocytopenia Contraindication to anticoagulation therapy Currently documented intracardiac thrombus or myxoma Implantation of permanent leads of an implantable device in or through the right atrium within 90 days of enrollment Prosthetic valve through which the catheter must pass Interatrial baffle or patch through which the catheter must pass Moderate or severe tricuspid valve regurgitation or stenosis Uncompensated congestive heart failure Active systemic infection Pregnancy Uncontrolled hyperthyroidism Any other significant uncontrolled or unstable medical condition Enrollment in any concurrent study without Imricor written approval Life expectancy of less than or equal to 2 years (730 days) per physician opinion

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Vision-MR Atrial Flutter Ablation

    Arm Description

    Type 1 Atrial Flutter ablation performed in the iCMR with the Vision-MR Ablation Catheter 2.0 and associated Advantage-MR EP recorder and stimulator system.

    Outcomes

    Primary Outcome Measures

    Primary Efficacy Endpoint: Bi-directional block confirmation
    Confirmation of bidirectional conduction block of the CTI with the Vision-MR Ablation Catheter 2.0 and Osypka HAT 500 RF generator & irrigation pump.
    Primary Safety Endpoint: Composite of serious cardiovascular adverse events
    A composite of the following serious adverse events as adjudicated by an independent clinical events committee: Cardiac perforation/tamponade Cerebrovascular accident (CVA) Transient ischemic attack (TIA) Complete heart block Myocardial infarction Pulmonary embolism MR-related serious adverse events Unanticipated device related serious adverse events Death

    Secondary Outcome Measures

    Chronic Efficacy Endpoint: Freedom from type 1 atrial flutter at 90 days
    The percent of subjects free of documented type I atrial flutter recurrence
    Chronic Safety Endpoint: all serious adverse event rate for duration of study
    Rate of Serious Adverse Events during the clinical investigation as adjudicated by an independent clinical events committee

    Full Information

    First Posted
    April 13, 2023
    Last Updated
    June 30, 2023
    Sponsor
    Imricor Medical Systems
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05904548
    Brief Title
    Atrial Flutter Ablation in the iCMR
    Acronym
    VISABL-AFL
    Official Title
    Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2023 (Anticipated)
    Primary Completion Date
    December 15, 2023 (Anticipated)
    Study Completion Date
    December 15, 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
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The VISABL-AFL clinical investigation is a prospective, single-arm, multi-center, interventional, Investigational Device Exemption (IDE) trial. The primary objectives of VISABL-AFL are to assess the safety and efficacy of radiofrequency (RF) ablation of type-I atrial flutter 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
    Atrial Flutter Typical
    Keywords
    RF Ablation, interventional Cardiac Magnetic Resonance (iCMR)

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Vision-MR Atrial Flutter Ablation
    Arm Type
    Experimental
    Arm Description
    Type 1 Atrial Flutter ablation performed in the iCMR with the Vision-MR Ablation Catheter 2.0 and associated Advantage-MR EP recorder and stimulator system.
    Intervention Type
    Device
    Intervention Name(s)
    RF Ablation
    Intervention Description
    RF ablation for type I atrial flutter under iCMR guidance
    Primary Outcome Measure Information:
    Title
    Primary Efficacy Endpoint: Bi-directional block confirmation
    Description
    Confirmation of bidirectional conduction block of the CTI with the Vision-MR Ablation Catheter 2.0 and Osypka HAT 500 RF generator & irrigation pump.
    Time Frame
    Time of procedure, following delivery of last ablation energy delivery point
    Title
    Primary Safety Endpoint: Composite of serious cardiovascular adverse events
    Description
    A composite of the following serious adverse events as adjudicated by an independent clinical events committee: Cardiac perforation/tamponade Cerebrovascular accident (CVA) Transient ischemic attack (TIA) Complete heart block Myocardial infarction Pulmonary embolism MR-related serious adverse events Unanticipated device related serious adverse events Death
    Time Frame
    7-days post procedure
    Secondary Outcome Measure Information:
    Title
    Chronic Efficacy Endpoint: Freedom from type 1 atrial flutter at 90 days
    Description
    The percent of subjects free of documented type I atrial flutter recurrence
    Time Frame
    3 months (90 days)
    Title
    Chronic Safety Endpoint: all serious adverse event rate for duration of study
    Description
    Rate of Serious Adverse Events during the clinical investigation as adjudicated by an independent clinical events committee
    Time Frame
    3 months (90 days)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient indicated for type I atrial flutter ablations with at least 1 documented episode of type I atrial flutter within 6 months (180 days) of enrollment Patient 18 years and older Exclusion Criteria: Contraindications for MRI procedures Patients who cannot have anti-arrhythmic drugs (class I or class III) prescribed for the treatment of type I atrial flutter stopped on the day of the procedure Previous CTI ablation procedures Myocardial infarction within 60 days of enrollment Current unstable angina Cardiac surgery within 90 days of enrollment Any cerebral ischemic event (including transient ischemic attacks) within 6 months (180 days) of enrollment Thrombocytosis or thrombocytopenia Contraindication to anticoagulation therapy Currently documented intracardiac thrombus or myxoma Implantation of permanent leads of an implantable device in or through the right atrium within 90 days of enrollment Prosthetic valve through which the catheter must pass Interatrial baffle or patch through which the catheter must pass Moderate or severe tricuspid valve regurgitation or stenosis Uncompensated congestive heart failure Active systemic infection Pregnancy Uncontrolled hyperthyroidism Any other significant uncontrolled or unstable medical condition Enrollment in any concurrent study without Imricor written approval Life expectancy of less than or equal to 2 years (730 days) per physician opinion
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kate Lindborg, PhD
    Phone
    9528188400
    Email
    kate.lindborg@imricor.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kate Lindborg, PhD
    Organizational Affiliation
    Imricor Medical Systems, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Atrial Flutter Ablation in the iCMR

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