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Prophylactic Substrate Ablation in Post-myocardial Patients Undergoing Defibrillator Implantation.

Primary Purpose

Heart Failure, Myocardial Infarction, Ventricular Tachycardia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ventricular tachycardia substrate ablation
Sponsored by
Spyridon Deftereos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring Ventricular tachycardia, Ablation, Myocardial Infarction, Heart Failure

Eligibility Criteria

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

Inclusion Criteria:

  • Post-MI patients eligible for ICD implantation in the setting of primary prevention

Exclusion Criteria:

  1. NYHA IV or ambulatory NYHA IV
  2. Acute coronary syndrome in the last 40 days
  3. Stable angina not eligible to revascularization
  4. Revascularization in the last 3 months (except MI)
  5. Antiarrhythmic therapy other than b-blockers
  6. LVEF<20%
  7. GFR<30ml/min/1.73m2
  8. Systematic illnesses

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Prophylactic substrate ablation group

    Control group

    Arm Description

    Prophylactic substrate ablation group will undergo substrate mapping and ventricular tachycardia substrate ablation

    Control group will undergo substrate mapping

    Outcomes

    Primary Outcome Measures

    Appropriate ICD activation therapies
    All post-MI patients will undergo ICD implantation and electroanatomical substrate mapping of the left ventricle. Half patients will also undergo prophylactic VT ablation aiming to late and early potentials elimination. Post-MI patients who underwent ICD implantation in the setting of primary prevention and prophylactic substrate ablation will have significant less appropriate ICD therapies.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 19, 2016
    Last Updated
    May 19, 2016
    Sponsor
    Spyridon Deftereos
    Collaborators
    Biosense Webster, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02780947
    Brief Title
    Prophylactic Substrate Ablation in Post-myocardial Patients Undergoing Defibrillator Implantation.
    Official Title
    Prophylactic Substrate Ablation in Post-myocardial Patients Undergoing Defibrillator Implantation.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2016 (undefined)
    Primary Completion Date
    June 2020 (Anticipated)
    Study Completion Date
    June 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Spyridon Deftereos
    Collaborators
    Biosense Webster, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Prophylactic substrate ablation in post-MI patients undergoing defibrillator implantation reduces appropriate defibrillator therapies.
    Detailed Description
    Background In patients with Ventricular Tachycardia (VT) and structural heart disease, the Implanted Cardioverter Defibrillator (ICD), provides a significant protection against the risk of sudden death, however it does not prevent arrhythmia recurrences [1-7]. ICD therapies, especially shocks, pose several risks, including decreased quality of life, increased mortality among patients who suffer ICD shock compared with patients who do not and clinically significant anxiety and depression as a result of recurrent ICD shocks, which has been found to occur in more than 50% of patients [8-12]. Furthermore, ICD implantation has been found not to protect against sudden cardiac death in 3-7% of patients [13]. The benefit of novel ICD programming in reducing inappropriate ICD therapy and mortality was demonstrated in Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) [14]. Catheter ablation has been considered a plausible curative therapy for VT prevention, especially in patients with VT episodes [15]. The Substrate Mapping and Ablation in Sinus Rhythm to Halt Ventricular Tachycardia (SMASH-VT) and the Ventricular Tachycardia Ablation in Coronary Heart Disease (VTACH) found that prophylactic catheter ablation reduces the incidence of appropriate ICD therapy in patients who had undergone ICD implantation as a means of secondary prevention and had a history of myocardial infarction (MI) [16,17]. It was also shown in a small retrospective study that prophylactic catheter ablation for induced VT reduced the incidence of appropriate ICD therapy in primary prevention post-MI patients [18]. Aim of the study - Statement of Hypothesis Prophylactic substrate ablation in post-MI patients undergoing defibrillator implantation reduces appropriate defibrillator therapies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Myocardial Infarction, Ventricular Tachycardia
    Keywords
    Ventricular tachycardia, Ablation, Myocardial Infarction, Heart Failure

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Prophylactic substrate ablation group
    Arm Type
    Active Comparator
    Arm Description
    Prophylactic substrate ablation group will undergo substrate mapping and ventricular tachycardia substrate ablation
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Control group will undergo substrate mapping
    Intervention Type
    Procedure
    Intervention Name(s)
    Ventricular tachycardia substrate ablation
    Intervention Description
    Study protocol Baseline programmed ventricular stimulation performed from the LV High density endocardial LV mapping using CARTO® 3 System Randomized substrate ablation in half patients. Ablation end-point is considered the elimination of all endocardial late and early potentials (LPs and EPs) Final programmed ventricular stimulation performed from the LV Programmed ventricular stimulation with up to 4 extrastimuli from LV is performed and repeated at the end of the procedure in patients undergoing substrate ablation.
    Primary Outcome Measure Information:
    Title
    Appropriate ICD activation therapies
    Description
    All post-MI patients will undergo ICD implantation and electroanatomical substrate mapping of the left ventricle. Half patients will also undergo prophylactic VT ablation aiming to late and early potentials elimination. Post-MI patients who underwent ICD implantation in the setting of primary prevention and prophylactic substrate ablation will have significant less appropriate ICD therapies.
    Time Frame
    Within 3 years after ICD implantation

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Post-MI patients eligible for ICD implantation in the setting of primary prevention Exclusion Criteria: NYHA IV or ambulatory NYHA IV Acute coronary syndrome in the last 40 days Stable angina not eligible to revascularization Revascularization in the last 3 months (except MI) Antiarrhythmic therapy other than b-blockers LVEF<20% GFR<30ml/min/1.73m2 Systematic illnesses
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Spyros Deftereos, MD
    Phone
    +306944699901
    Email
    spdeftereos@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dimitris Tsiachris, MD
    Phone
    +306944849926
    Email
    dtsiachris@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    George Giannopoulos, MD
    Organizational Affiliation
    Attikon Hospital, University of Athens
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Charis Kossyvakis, MD
    Organizational Affiliation
    Athens General Hospital "G. Gennimatas"
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Spyros Deftereos, MD
    Organizational Affiliation
    Attikon Hospital, University of Athens
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Dimitris Tsiachris, MD
    Organizational Affiliation
    Athens Heart Center, Athens Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    31698933
    Citation
    Kheiri B, Barbarawi M, Zayed Y, Hicks M, Osman M, Rashdan L, Kyi HH, Bachuwa G, Hassan M, Stecker EC, Nazer B, Bhatt DL. Antiarrhythmic Drugs or Catheter Ablation in the Management of Ventricular Tachyarrhythmias in Patients With Implantable Cardioverter-Defibrillators: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Circ Arrhythm Electrophysiol. 2019 Nov;12(11):e007600. doi: 10.1161/CIRCEP.119.007600. Epub 2019 Nov 8.
    Results Reference
    derived

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    Prophylactic Substrate Ablation in Post-myocardial Patients Undergoing Defibrillator Implantation.

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