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Physiologically Guided VT Ablation

Primary Purpose

Ventricular Tachycardia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ablation
Sponsored by
Center for Cardiovascular Reseach and Innovation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Tachycardia

Eligibility Criteria

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

Inclusion Criteria:

  1. Age ≥18 years
  2. History of myocardial infarction ≥1month before enrolment documented by ECG or cardiac imaging (TTE, SPECT, CMR).
  3. Planned for first VT ablation procedure.
  4. Patients must have an ICD or a plan for ICD implantation after the ablation.
  5. Ability to understand the requirement of the study and to sign an informed consent.

Exclusion Criteria:

  1. Patients requiring long-term treatment with class I or class III antiarrhythmic drugs after ablation (for AF).
  2. The VT substrate is thought not to be related to coronary disease.
  3. Presence of ongoing ischemia that is thought to be the cause of the VT.
  4. Contraindication to anticoagulation therapy
  5. Stroke within 30 days before enrollment.
  6. Life expectancy <1 year for any medical condition.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Study Arm

    Control

    Arm Description

    The left ventricle is mapped during atrial and right or left ventricular pacing (site close to the infarct) at a similar cycle length of 600ms. Radio-frequency ablation is performed selectively in areas of activation slowing (defined as ≤40ms per 5mm while voltage abnormalities and late potentials were not specifically targeted.

    Patient who underwent ablation using similar technology and irrigated catheters guided by standard substrate mapping techniques.

    Outcomes

    Primary Outcome Measures

    Composite of VT recurrence or death

    Secondary Outcome Measures

    Full Information

    First Posted
    June 28, 2019
    Last Updated
    June 28, 2019
    Sponsor
    Center for Cardiovascular Reseach and Innovation
    Collaborators
    Boston Scientific Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04004624
    Brief Title
    Physiologically Guided VT Ablation
    Official Title
    Physiologically Guided Ablation of Reentry-Vulnerable-Zones for the Treatment of Post-Infarction Ventricular Tachycardia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 12, 2014 (Actual)
    Primary Completion Date
    September 16, 2019 (Anticipated)
    Study Completion Date
    January 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Center for Cardiovascular Reseach and Innovation
    Collaborators
    Boston Scientific Corporation

    4. Oversight

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

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the efficacy of VT ablation guided by functional evaluation of the substrate to specifically target the reentry-vulnerable zones in patients with infarct-related VT.
    Detailed Description
    Activation mapping of VT is the gold-standard method for description of the reentrant circuit and identification of its isthmus, however this is uncommonly accomplished due to hemodynamic non-tolerance and limited temporal and spatial resolution. Substrate mapping has been developed as an alternative method to identify the isthmus of post-infarction VT during sinus rhythm (SR). However, it has limited specificity to critical VT sites. Fundamental work in animal models of healed infarction and humans has shown that the VT isthmus corresponds to locations characterized by marked activation slowing during SR. Furthermore, these locations serve as "anchors" for multiple VT morphologies and cycle lengths. The hypothesis of this study is that activation mapping during SR or pacing can improve the specifically for identifying the critical VT sites. The aim of this prospective, multi-center controlled study is to evaluate the utility and limitations of functional mapping for guiding ablation of reentry vulnerably zones for long-term control of VT

    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
    Model Description
    This prospective, multi-center controlled study enrolles patients with infarct-related VT refractory to anti-arrhythmic drugs. The outcome of the study group will be compared to historical control group of patients matched for age, LVEF and VT burden.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study Arm
    Arm Type
    Active Comparator
    Arm Description
    The left ventricle is mapped during atrial and right or left ventricular pacing (site close to the infarct) at a similar cycle length of 600ms. Radio-frequency ablation is performed selectively in areas of activation slowing (defined as ≤40ms per 5mm while voltage abnormalities and late potentials were not specifically targeted.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Patient who underwent ablation using similar technology and irrigated catheters guided by standard substrate mapping techniques.
    Intervention Type
    Device
    Intervention Name(s)
    Ablation
    Intervention Description
    Cardiac Ablation
    Primary Outcome Measure Information:
    Title
    Composite of VT recurrence or death
    Time Frame
    36 months follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥18 years History of myocardial infarction ≥1month before enrolment documented by ECG or cardiac imaging (TTE, SPECT, CMR). Planned for first VT ablation procedure. Patients must have an ICD or a plan for ICD implantation after the ablation. Ability to understand the requirement of the study and to sign an informed consent. Exclusion Criteria: Patients requiring long-term treatment with class I or class III antiarrhythmic drugs after ablation (for AF). The VT substrate is thought not to be related to coronary disease. Presence of ongoing ischemia that is thought to be the cause of the VT. Contraindication to anticoagulation therapy Stroke within 30 days before enrollment. Life expectancy <1 year for any medical condition.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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