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VIVO Mapping Protocol

Primary Purpose

Ventricular Tachycardia, Ventricular Ectopic Beat(S)

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VIVO non invasive mapping
Sponsored by
Royal Brompton & Harefield NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ventricular Tachycardia

Eligibility Criteria

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

Inclusion Criteria:

  1. Subjects who are at least 18 years or older
  2. Subjects who are scheduled for PVC/VT ablation procedure
  3. Subjects who have signed an IRB/EC approved Informed Consent Form and applicable subject privacy protection authorization per local law
  4. Subjects will be selected without regard to gender or age (unless precluded by local regulatory requirements)
  5. Subjects with or without cardiac structural disease

Exclusion Criteria:

  1. Reversible causes of PVC/VT
  2. Subjects with recent (within 3 months) acute coronary syndrome
  3. Subjects who are contraindicated for CT or MRI (must be able to get one)
  4. Subject whose MRI or CT scan does not comply with the requirements of this protocol
  5. Subjects who are contraindicated for an electrophysiology procedure and/or fluoroscopy:

    • INR > 3.5
    • Active infection
    • Pregnancy: Females of childbearing potential with a positive pregnancy test.
  6. Existing mechanical heart valve
  7. Subjects with structural cardiac disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    VIVO mapping pre-procedure

    Arm Description

    15 patients with structurally normal heart and indication for PVC/VT catheter ablation, who will undergo pre-procedural non invasive mapping with VIVO mapping system.

    Outcomes

    Primary Outcome Measures

    Reduction of procedural time (in minutes)
    Use of VIVO mapping to localize the PVC / VT origin prior to the catheter procedure in order to change procedural time. Procedural time is meant to be measured in minutes per procedure, and it is normally considered from "puncture time" to "sheaths removal".
    Safety - absence of acute adverse events using VIVO system for non-invasive mapping
    Absence of acute adverse events due to the use of VIVO system during PVC/VT ablation in the cohort of patients enrolled for the study. Acute adverse events are described in section 12 of the study protocol and will be reported in specific forms to the Sponsor and REC.
    Safety 2 - absence of acute adverse events using VIVO system for mapping and during the whole ablation procedure
    Safety endpoint of the entire mapping and ablation strategy, determined by the absence of adverse events (AEs).

    Secondary Outcome Measures

    economical outcome: change of procedural costs
    To assess economical outcome, which is meant as cost change (in pounds) per number of cases
    clinical outcome assessed as change of PVCs/VT burden
    Count of PVC/VT burden at 3-month follow up Holter (expressed as No. / 24 hours)

    Full Information

    First Posted
    May 4, 2019
    Last Updated
    June 19, 2019
    Sponsor
    Royal Brompton & Harefield NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03994068
    Brief Title
    VIVO Mapping Protocol
    Official Title
    VIVO Non-invasive Time Assessment Protocol
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2019 (Anticipated)
    Primary Completion Date
    January 1, 2020 (Anticipated)
    Study Completion Date
    May 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Royal Brompton & Harefield NHS Foundation Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a single centre study enrolling 15 subjects with structurally normal hearts that are already indicated for a ventricular ablation procedure (VT or PVCs). The purpose is to compare the accuracy of VIVO and to assess its efficacy to decrease procedural time, and ideally, the procedural overall costs, as compared to standard of care ablation procedures. Results will be compared with data from
    Detailed Description
    VIVO TM is a non invasive mapping system which can be used to localize PVC / VT origin prior to the ablative procedure. Subjects scheduled for catheter ablation with VIVO will undergo a CT scan prior to the procedure, which will be used to create a personalized 3D model. This will be merged with a 3D photograph (taken at the start of the procedure) of the ECG electrodes on the subject's torso. Then, the recording of the 12 lead ECG will be imported into the VIVO software. All of this data will be combined via the software and a mathematical algorithm will determine the origin of the arrhythmia. This will show the physician where to perform a successful ablation. After 3 months, the subject will return for follow up and will receive another ECG Holter monitor (ECG recording) to determine ablation success. Subjects will be exited from the study after the 3 month follow up visit. Patients will receive standard clinical care prior to, during and after their scheduled procedure, as well as after being discarded from the trial. Results will be analysed and compared to those from an historical cohort of patients (age / gender matched, undergone the same procedure) ablated by the same operator within the previous 5 years (from a database already collected). Data will be anonymised as per current regulations.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ventricular Tachycardia, Ventricular Ectopic Beat(S)

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    VIVO mapping pre-procedure
    Arm Type
    Experimental
    Arm Description
    15 patients with structurally normal heart and indication for PVC/VT catheter ablation, who will undergo pre-procedural non invasive mapping with VIVO mapping system.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    VIVO non invasive mapping
    Intervention Description
    non invasive pre-procedural localization of PVC / VT origin
    Primary Outcome Measure Information:
    Title
    Reduction of procedural time (in minutes)
    Description
    Use of VIVO mapping to localize the PVC / VT origin prior to the catheter procedure in order to change procedural time. Procedural time is meant to be measured in minutes per procedure, and it is normally considered from "puncture time" to "sheaths removal".
    Time Frame
    three months
    Title
    Safety - absence of acute adverse events using VIVO system for non-invasive mapping
    Description
    Absence of acute adverse events due to the use of VIVO system during PVC/VT ablation in the cohort of patients enrolled for the study. Acute adverse events are described in section 12 of the study protocol and will be reported in specific forms to the Sponsor and REC.
    Time Frame
    three months
    Title
    Safety 2 - absence of acute adverse events using VIVO system for mapping and during the whole ablation procedure
    Description
    Safety endpoint of the entire mapping and ablation strategy, determined by the absence of adverse events (AEs).
    Time Frame
    three months
    Secondary Outcome Measure Information:
    Title
    economical outcome: change of procedural costs
    Description
    To assess economical outcome, which is meant as cost change (in pounds) per number of cases
    Time Frame
    three months
    Title
    clinical outcome assessed as change of PVCs/VT burden
    Description
    Count of PVC/VT burden at 3-month follow up Holter (expressed as No. / 24 hours)
    Time Frame
    three months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects who are at least 18 years or older Subjects who are scheduled for PVC/VT ablation procedure Subjects who have signed an IRB/EC approved Informed Consent Form and applicable subject privacy protection authorization per local law Subjects will be selected without regard to gender or age (unless precluded by local regulatory requirements) Subjects with or without cardiac structural disease Exclusion Criteria: Reversible causes of PVC/VT Subjects with recent (within 3 months) acute coronary syndrome Subjects who are contraindicated for CT or MRI (must be able to get one) Subject whose MRI or CT scan does not comply with the requirements of this protocol Subjects who are contraindicated for an electrophysiology procedure and/or fluoroscopy: INR > 3.5 Active infection Pregnancy: Females of childbearing potential with a positive pregnancy test. Existing mechanical heart valve Subjects with structural cardiac disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sabine Ernst, MD, PhD
    Phone
    00442073518612
    Email
    s.ernst@rbht.nhs.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ilaria Cazzoli, MD
    Email
    I.Cazzoli@rbht.nhs.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sabine Ernst, MD, PhD
    Organizational Affiliation
    Royal Brompton and Harefield Hospital Trust
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ilaria Cazzoli, MD
    Organizational Affiliation
    Royal Brompton and Harefield Hospital Trust
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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