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Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy (EPIC-VT) (EPIC-VT)

Primary Purpose

Ischemic Cardiomyopathy, Catheter Ablation of Ventricular Tachycardia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endo-epicardial ablation
endocardial ablation only
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Cardiomyopathy focused on measuring ischemic cardiomyopathy

Eligibility Criteria

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

Inclusion Criteria: Patients over 18 years of age 1st radiofrequency ablation of VT complicating ischaemic heart disease Patients with an ICD and remote monitoring Having, for women of childbearing age, effective contraception until discharge from hospital Have given their free and informed consent in writing are affiliated to or have health insurance Exclusion Criteria: History of cardiac surgery compromising the epicardial approach (coronary artery bypas s grafting, valve replacements, or other surgeries that may have caused pericardial adhesions) Anticoagulant therapy that cannot be temporarily discontinued Double antiplatelet therapy that cannot be temporarily replaced by single antiplatelet therapy History of pericarditis Previous thoracic radiotherapy Contraindication to general anaesthesia Pregnant or breastfeeding woman History of heparin-induced thrombocytopenia type 2 (as injection is required during the procedure) Person under legal protection (safeguard of justice, curatorship, guardianship), deprived of liberty, or unable to express consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Endo-epicardial ablation

    endocardial ablation only

    Arm Description

    Outcomes

    Primary Outcome Measures

    Survival free from ventricular arrhythmia recurrence
    Survival free from ventricular arrhythmia recurrence, defined as the time interval between the date of ablation and the date of first ventricular arrhythmia recurrence. Recurrence of ventricular arrhythmia is defined as the occurrence of appropriate ICD therapy or the occurrence of sustained VT/VF > 30 seconds The occurrence of the event and the date of the event will be obtained from the ICD interrogation. Patients without recurrence will be censored at the date of last ICD interrogation

    Secondary Outcome Measures

    Number of ventricular arrhythmias treated
    Number of ventricular arrhythmias treated by the defibrillator with shocks or bursts of antitachycardia pacing during follow-up or the occurrence of sustained VT/VF > 30 seconds.
    Percentage of patients with recurrent ventricular arrhythmia
    Percentage of patients with recurrent ventricular arrhythmia
    Percentage of patients with a electrical storm
    Electrical storm is defined as the occurrence of at least 3 appropriate therapies (antitachycardia pacing or shocks) delivered by the defibrillator within 24 hours.
    Number of serious complications
    Number of serious complications related to the procedure
    Number of patients hospitalized for cardiovascular reasons
    Number of patients hospitalized for cardiovascular reasons (i.e. heart failure, rhythm disorders) at 2 years
    Number of patients requiring a redo ablation for ventricular arrhythmia
    Number of patients requiring a redo ablation for ventricular arrhythmia
    mortality rate
    2-year mortality rate
    Number of patients in each group who are non-inducible at the end of the procedure
    Number of patients in each group who are non-inducible at the end of the procedure (programmed ventricular stimulation negative)

    Full Information

    First Posted
    May 15, 2023
    Last Updated
    May 24, 2023
    Sponsor
    Rennes University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05888662
    Brief Title
    Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy (EPIC-VT)
    Acronym
    EPIC-VT
    Official Title
    Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients Withischemic Cardiomyopathy: a Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2028 (Anticipated)
    Study Completion Date
    June 1, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rennes University Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    Radiofrequency ablation of ventricular tachycardias (VTs) is the gold standard treatment of refractory VTs in patients with ischaemic heart disease. In this setting, ablation is usually performed endocardially. However, even after a procedural success there is a high risk of recurrence, particularly due to the inability to create transmural lesions. Indeed, only the endocardium of the LV has been ablated, while a significant part of the arrhythmia substrate may be located on the other side of the myocardial thickness, on the epicardial side of the LV. First described in 1996, epicardial ablation, performed via a percutaneous subxyphoid approach, has since undergone considerable development. Electrophysiologists often use a double endo- and epicardial approach as first line therapy for the ablation of VTs complicating myocarditis or arrhythmogenic dysplasia of the right ventricle, where the substrate is most often epicardial. For VT in ischaemic heart disease, electrophysiologists perform endocardial ablation, and often perform epicardial ablation only after several endocardial failures. Several observational studies suggest that a combined endo- and epicardial approach as first line therapy is associated with a reduced risk of VT recurrence. Since recurrent VT in patients with ischaemic heart disease as a prognostic impact in terms of morbidity and mortality, it appears essential to optimise rhythm management by ablation, by offering a combined approach from the as first approach to reduce the risk of recurrences. The aim of our prospective, multicentre, controlled, randomized study is therefore to compare the rate of VT recurrence after ablation performed as first line therapy either by endocardial approach alone or by combined endo-epicardial approach.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Cardiomyopathy, Catheter Ablation of Ventricular Tachycardia
    Keywords
    ischemic cardiomyopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Endo-epicardial ablation
    Arm Type
    Experimental
    Arm Title
    endocardial ablation only
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Endo-epicardial ablation
    Intervention Description
    Endo-epicardial ablation of ventricular tachycardia
    Intervention Type
    Procedure
    Intervention Name(s)
    endocardial ablation only
    Intervention Description
    endocardial-only catheter ablation of ventricular tachycardia
    Primary Outcome Measure Information:
    Title
    Survival free from ventricular arrhythmia recurrence
    Description
    Survival free from ventricular arrhythmia recurrence, defined as the time interval between the date of ablation and the date of first ventricular arrhythmia recurrence. Recurrence of ventricular arrhythmia is defined as the occurrence of appropriate ICD therapy or the occurrence of sustained VT/VF > 30 seconds The occurrence of the event and the date of the event will be obtained from the ICD interrogation. Patients without recurrence will be censored at the date of last ICD interrogation
    Time Frame
    up to 5 years
    Secondary Outcome Measure Information:
    Title
    Number of ventricular arrhythmias treated
    Description
    Number of ventricular arrhythmias treated by the defibrillator with shocks or bursts of antitachycardia pacing during follow-up or the occurrence of sustained VT/VF > 30 seconds.
    Time Frame
    up to 5 years
    Title
    Percentage of patients with recurrent ventricular arrhythmia
    Description
    Percentage of patients with recurrent ventricular arrhythmia
    Time Frame
    up to 5 years
    Title
    Percentage of patients with a electrical storm
    Description
    Electrical storm is defined as the occurrence of at least 3 appropriate therapies (antitachycardia pacing or shocks) delivered by the defibrillator within 24 hours.
    Time Frame
    up to 5 years
    Title
    Number of serious complications
    Description
    Number of serious complications related to the procedure
    Time Frame
    up to 5 years
    Title
    Number of patients hospitalized for cardiovascular reasons
    Description
    Number of patients hospitalized for cardiovascular reasons (i.e. heart failure, rhythm disorders) at 2 years
    Time Frame
    up to 2 years
    Title
    Number of patients requiring a redo ablation for ventricular arrhythmia
    Description
    Number of patients requiring a redo ablation for ventricular arrhythmia
    Time Frame
    Up to 5 years
    Title
    mortality rate
    Description
    2-year mortality rate
    Time Frame
    Up to 2 years
    Title
    Number of patients in each group who are non-inducible at the end of the procedure
    Description
    Number of patients in each group who are non-inducible at the end of the procedure (programmed ventricular stimulation negative)
    Time Frame
    1 day
    Other Pre-specified Outcome Measures:
    Title
    Procedure duration
    Description
    Procedure time (from puncture to catheter removal, in minutes) and duration of radiofrequency delivery (in minutes)
    Time Frame
    1 day
    Title
    Percentage of patients with inappropriate therapies deliverd by the ICD
    Description
    Percentage of patients with inappropriate therapies deliverd by the ICD at 2 years
    Time Frame
    Up to 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients over 18 years of age 1st radiofrequency ablation of VT complicating ischaemic heart disease Patients with an ICD and remote monitoring Having, for women of childbearing age, effective contraception until discharge from hospital Have given their free and informed consent in writing are affiliated to or have health insurance Exclusion Criteria: History of cardiac surgery compromising the epicardial approach (coronary artery bypas s grafting, valve replacements, or other surgeries that may have caused pericardial adhesions) Anticoagulant therapy that cannot be temporarily discontinued Double antiplatelet therapy that cannot be temporarily replaced by single antiplatelet therapy History of pericarditis Previous thoracic radiotherapy Contraindication to general anaesthesia Pregnant or breastfeeding woman History of heparin-induced thrombocytopenia type 2 (as injection is required during the procedure) Person under legal protection (safeguard of justice, curatorship, guardianship), deprived of liberty, or unable to express consent
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Raphaël MARTINS, MD, PhD
    Phone
    299282517
    Ext
    33
    Email
    raphael.martins@chu-rennes.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kristell COAT
    Phone
    299282555
    Ext
    33
    Email
    kristell.coat@chu-rennes.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Raphaël MARTINS, MD, PhD
    Organizational Affiliation
    Rennes University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy (EPIC-VT)

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