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Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation (PROFID EHRA)

Primary Purpose

Sudden Cardiac Death, Myocardial Infarction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Implantable cardioverter-defibrillator (ICD)
Optimal Medical Therapy (OMT)
Sponsored by
Leipzig Heart Science gGmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sudden Cardiac Death focused on measuring Implantable Cardioverter Defibrillator, Sudden Cardiac Death, Myocardial Infarction

Eligibility Criteria

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

Inclusion Criteria: Age ≥18 years. Naïve to implantation of any pacemaker or defibrillator Documented history of MI either as ST segment elevation myocardial infarction (STEMI) or as non-ST segment elevation myocardial infarction (NSTEMI) at least 3 months prior to enrolment. Symptomatic heart failure with New York Heart Association (NYHA) class II or III. On OMT for at least 3 months prior to enrolment. LVEF ≤ 35% (at transthoracic echocardiography or cardiac magnetic resonance imaging [MRI] at least 3 months after MI and at least 3 months prior to enrolment. Signed informed consent. Inclusion criterion I3 defines myocardial infarction according to the 2018 ESC/ACC/AHA/WHF Fourth Universal Definition of myocardial infarction Exclusion Criteria: Class I or IIa indication for implantation of an ICD for secondary prevention of SCD and ventricular tachycardia. Ventricular tachycardia induced in an electrophysiologic study. Unexplained syncope when ventricular arrhythmia is suspected as the cause of syncope. Class I or IIa indication for Cardiac Resynchronization Therapy (CRT) Foreseable violation of instruction for use (IFU) of the ICD device selected for implantation (valid for control group patients, only). Acute coronary syndrome or coronary angioplasty or coronary artery bypass grafting performed within 6 weeks prior to enrolment. Cardiac valve surgery or percutaneous cardiac valvular intervention performed within 6 weeks prior to enrolment. On the waiting list for heart transplantation. Class I or IIa indication for implantation of an ICD for secondary prevention of SCD and ventricular tachy-cardia has to be assessed according to the 2022 ESC Guidelines for the management of patients with ven-tricular arrhythmias and the prevention of SCD. Any known disease that limits life expectancy to less than 1 year. Participation in another randomised clinical trial, either within the 3 months prior to enrolment or still on-going. Previous participation in PROFID EHRA. Parallel participation in sub-studies connected to this trial is permitted as well as in purely observational studies without any pre-defined intervention.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Optimal Medical Therapy with ICD device therapy

    Optimal Medical Therapy without ICD device therapy

    Arm Description

    Patients will be treated according to Optimal Medical Therapy defined by ESC Guidelines for treatment of patients with heart failure / chronic coronary syndromes and will receive an ICD device

    Patients will be treated according to Optimal Medical Therapy defined by ESC Guidelines for treatment of patients with heart failure / chronic coronary syndromes and will not receive an ICD device

    Outcomes

    Primary Outcome Measures

    Time from randomisation to the occurrence of all-cause death.
    Randomization to end of study

    Secondary Outcome Measures

    Time from randomisation to death from cardiovascular causes
    Time from randomisation to death from cardiovascular causes
    Time from randomisation to sudden cardiac death
    Time from randomisation to sudden cardiac death
    Time from randomisation to first hospital readmissions for cardiovascular causes after date of randomisation
    Time from randomisation to first hospital readmissions for cardiovascular causes after date of randomisation
    Average length of stay in hospital during the study period
    Average length of stay in hospital during the study period
    Quality of life (EQ-5D-5L) trajectories over time
    Quality of life (EQ-5D-5L) trajectories over time

    Full Information

    First Posted
    December 19, 2022
    Last Updated
    September 21, 2023
    Sponsor
    Leipzig Heart Science gGmbH
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05665608
    Brief Title
    Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation
    Acronym
    PROFID EHRA
    Official Title
    Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    April 30, 2027 (Anticipated)
    Study Completion Date
    April 30, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Leipzig Heart Science gGmbH

    4. Oversight

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

    5. Study Description

    Brief Summary
    Patients who have survived a myocardial infarction (MI) are at increased risk for sudden cardiac death (SCD) caused by ventricular tachycardia and ventricular fibrillation. A severely reduced left ventricular ejection fraction (LVEF) as a rough overall measure of impaired heart function after MI was shown to indicate a higher risk for SCD. Based on this observation, two landmark randomised trials, MADIT II and SCD-HeFT, were conducted between end of the 1990s and early 2000s. These trials compared the survival of patients with severely reduced LVEF who received an implantable cardioverter-defibrillator with the survival of patients being on medical therapy alone. They reported a significantly better survival of patients in the defibrillator arm and led to international guideline recommendations for routine implantation of defibrillators in survivors of MI with severely impaired LVEF as a means for primary prevention of SCD. Since then, the management of these patients has changed dramatically with the advent of a series of novel drug classes that reduce not only mortality but specifically SCD leading to a substantial decrease of the sudden death rates as well as of the rates of appropriate defibrillator therapies implanted for primary prevention of SCD. At the same time, the complication rates associated with the defibrilllator therapy remain significant without obvious decrease. Thus, the risk-benefit of routine defibrillator implantation for primary prevention of SCD in patients with severely reduced LVEF has substantially changed since the conduction of the landmark trials that established this therapy. Due to the inherent risks and considerable costs of the defibrillator, a novel randomised adequately powered assessment of the potential benefit or harm of the defibrillator in survivors of MI with reduced LVEF under contemporary optimal medical treatment (OMT) appears imperative. OBJECTIVE: To demonstrate that in post-MI patients with symptomatic heart failure who receive OMT for this condition, and with reduced LVEF ≤ 35%, OMT without ICD implantation (index group) is not inferior to OMT with ICD implantation (control group) with respect to all-cause mortality.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sudden Cardiac Death, Myocardial Infarction
    Keywords
    Implantable Cardioverter Defibrillator, Sudden Cardiac Death, Myocardial Infarction

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    An investigator-driven, prospective, parallel-group, randomised, open, blinded outcome assessment (PROBE), multi-centre, non-inferiority trial without investigational medical products (Proof of Strategy Trial)
    Masking
    None (Open Label)
    Masking Description
    The PROFID EHRA trial is an open-label, blinded outcome assessment study. Thus, unblinding procedures for investigators are not applicable.
    Allocation
    Randomized
    Enrollment
    3595 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Optimal Medical Therapy with ICD device therapy
    Arm Type
    Active Comparator
    Arm Description
    Patients will be treated according to Optimal Medical Therapy defined by ESC Guidelines for treatment of patients with heart failure / chronic coronary syndromes and will receive an ICD device
    Arm Title
    Optimal Medical Therapy without ICD device therapy
    Arm Type
    Experimental
    Arm Description
    Patients will be treated according to Optimal Medical Therapy defined by ESC Guidelines for treatment of patients with heart failure / chronic coronary syndromes and will not receive an ICD device
    Intervention Type
    Device
    Intervention Name(s)
    Implantable cardioverter-defibrillator (ICD)
    Intervention Description
    A transvenous ICD consists of an electronic medical device and electrode leads. Besides the possibility to shock during arrhythmias the ICD can potentially terminate ventricular tachycardias by rapid pacing for short periods (small bursts of pacing). The subcutaneous defibrillator is an established and valid alternative to the transvenous ICD for the prevention of SCD, but in patients without an indication for bradycardia support, cardiac resynchronisation or antitachycardia pacing. The extravascular implantable cardioverter-defibrillator (EV ICD) system with substernal lead placement is a novel nontransvenous alternative to current available transvenous and subcutaneous ICDs.
    Intervention Type
    Drug
    Intervention Name(s)
    Optimal Medical Therapy (OMT)
    Intervention Description
    Patients will be treated according to Optimal Medical Therapy defined by the following guidelines: 2019 ESC guidelines for the diagnosis and management of chronic coronary syndromes 2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure
    Primary Outcome Measure Information:
    Title
    Time from randomisation to the occurrence of all-cause death.
    Description
    Randomization to end of study
    Time Frame
    event-driven, expected about 15 months after last patient in
    Secondary Outcome Measure Information:
    Title
    Time from randomisation to death from cardiovascular causes
    Description
    Time from randomisation to death from cardiovascular causes
    Time Frame
    Randomization to end of study (event-driven, expected about 15 months after last patient in
    Title
    Time from randomisation to sudden cardiac death
    Description
    Time from randomisation to sudden cardiac death
    Time Frame
    Randomization to end of study (event-driven, expected about 15 months after last patient in
    Title
    Time from randomisation to first hospital readmissions for cardiovascular causes after date of randomisation
    Description
    Time from randomisation to first hospital readmissions for cardiovascular causes after date of randomisation
    Time Frame
    Randomization to end of study (event-driven, expected about 15 months after last patient in
    Title
    Average length of stay in hospital during the study period
    Description
    Average length of stay in hospital during the study period
    Time Frame
    Randomization to end of study (event-driven, expected about 15 months after last patient in
    Title
    Quality of life (EQ-5D-5L) trajectories over time
    Description
    Quality of life (EQ-5D-5L) trajectories over time
    Time Frame
    At baseline and 6-month intervals thereafter

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥18 years. Naïve to implantation of any pacemaker or defibrillator Documented history of MI either as ST segment elevation myocardial infarction (STEMI) or as non-ST segment elevation myocardial infarction (NSTEMI) at least 3 months prior to enrolment. Symptomatic heart failure with New York Heart Association (NYHA) class II or III. On OMT for at least 3 months prior to enrolment. LVEF ≤ 35% (at transthoracic echocardiography or cardiac magnetic resonance imaging [MRI] at least 3 months after MI and at least 3 months prior to enrolment. Signed informed consent. Inclusion criterion I3 defines myocardial infarction according to the 2018 ESC/ACC/AHA/WHF Fourth Universal Definition of myocardial infarction Exclusion Criteria: Class I or IIa indication for implantation of an ICD for secondary prevention of SCD and ventricular tachycardia. Ventricular tachycardia induced in an electrophysiologic study. Unexplained syncope when ventricular arrhythmia is suspected as the cause of syncope. Class I or IIa indication for Cardiac Resynchronization Therapy (CRT) Foreseable violation of instruction for use (IFU) of the ICD device selected for implantation (valid for control group patients, only). Acute coronary syndrome or coronary angioplasty or coronary artery bypass grafting performed within 6 weeks prior to enrolment. Cardiac valve surgery or percutaneous cardiac valvular intervention performed within 6 weeks prior to enrolment. On the waiting list for heart transplantation. Class I or IIa indication for implantation of an ICD for secondary prevention of SCD and ventricular tachy-cardia has to be assessed according to the 2022 ESC Guidelines for the management of patients with ven-tricular arrhythmias and the prevention of SCD. Any known disease that limits life expectancy to less than 1 year. Participation in another randomised clinical trial, either within the 3 months prior to enrolment or still on-going. Previous participation in PROFID EHRA. Parallel participation in sub-studies connected to this trial is permitted as well as in purely observational studies without any pre-defined intervention.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gerhard Hindricks, MD
    Phone
    +493418651410
    Email
    Gerhard.Hindricks@helios-gesundheit.de
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nikolaos Dagres, MD
    Phone
    +49341865252612
    Email
    Nikolaos.Dagres@helios-gesundheit.de
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gerhard Hindricks, MD
    Organizational Affiliation
    Department of Electrophysiology, Leipzig Heart Center at University of Leipzig
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Nikolaos Dagres, MD
    Organizational Affiliation
    Department of Electrophysiology, Leipzig Heart Center at University of Leipzig
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation

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