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Verifying Remote Monitoring Effect on Net Cardiovascular Outcome; RemoteVerify (RêVe) (ReVe)

Primary Purpose

Congestive Heart Failure, Defibrillators, Cardiac Resynchronization Therapy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
remote monitoring only
Sponsored by
Saint Vincent's Hospital, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congestive Heart Failure focused on measuring remote monitoring, congestive heart failure, Defibrillators, cardiac resynchronization therapy

Eligibility Criteria

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

Inclusion Criteria: consented heart failure patients (LVEF<=40%) with Biotronik wireless monitoring capable ICD/CRTs aged >20 years patients who are new to remote monitoring Exclusion Criteria: For patients with a life expectancy of less than 6 months. If patient do not understand the contents of wireless monitoring or it is difficult to fill out the consent form due to cognitive decline. If wireless monitoring is performed with a patient enrolled in another clinical trial which remote monitoring may affect the previous enrolled study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Follow up group

    Remote group

    Arm Description

    participants with experience of >6 months in-office device interrogation, then started remote monitoring

    participants with newly implanted device with study agreement, and then started remote monitoring

    Outcomes

    Primary Outcome Measures

    Unplanned early visits for cardiac causes1 (Patient)
    i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits
    Unplanned early visits for cardiac causes2 (Patient)
    i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits
    Unplanned early visits for cardiac causes3 (Patient)
    i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits
    Unplanned early visits for cardiac causes4 (Patient)
    i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits
    Unplanned early visits for cardiac causes1 (Clinic)
    ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits
    Unplanned early visits for cardiac causes2 (Clinic)
    ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits
    Unplanned early visits for cardiac causes3 (Clinic)
    ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits
    Unplanned early visits for cardiac causes4 (Clinic)
    ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits

    Secondary Outcome Measures

    Acute myocardial infarction (heart attack) or cerebrovascular events (stroke)
    ACS, CVA
    Thromboembolic events (such as pulmonary embolism)
    Systemic thromboembolic events
    Worsening of heart failure leading to hospitalization
    HF related admission
    Cardiac-related deaths
    Cardiac cause deaths
    Overall mortality
    overall deaths

    Full Information

    First Posted
    July 13, 2023
    Last Updated
    July 24, 2023
    Sponsor
    Saint Vincent's Hospital, Korea
    Collaborators
    Biotronik SE & Co. KG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05971225
    Brief Title
    Verifying Remote Monitoring Effect on Net Cardiovascular Outcome; RemoteVerify (RêVe)
    Acronym
    ReVe
    Official Title
    Prospective Multicenter Observation Study on the Association Between Remote Monitoring and Clinical Outcome in Heart Failure Patients (Verifying Remote Monitoring Effect on Net Cardiovascular Outcome; RemoteVerify (RêVe))
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 30, 2026 (Anticipated)
    Study Completion Date
    April 30, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Saint Vincent's Hospital, Korea
    Collaborators
    Biotronik SE & Co. KG

    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
    This study investigates the impact and safety of wireless monitoring on the prognosis of heart failure patients with implanted pacemakers and defibrillators. It aims to examine the frequency of unplanned early hospital visits and the early diagnosis/intervention of disease exacerbation based on the presence or absence of wireless monitoring. Additionally, the study analyzes the influence of wireless monitoring on the patient's disease progression as well as satisfaction of the study participants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Congestive Heart Failure, Defibrillators, Cardiac Resynchronization Therapy
    Keywords
    remote monitoring, congestive heart failure, Defibrillators, cardiac resynchronization therapy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    one group with experience of in-office device monitoring >6 months the other group without experience of in-office device monitoring
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    450 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Follow up group
    Arm Type
    Active Comparator
    Arm Description
    participants with experience of >6 months in-office device interrogation, then started remote monitoring
    Arm Title
    Remote group
    Arm Type
    Experimental
    Arm Description
    participants with newly implanted device with study agreement, and then started remote monitoring
    Intervention Type
    Other
    Intervention Name(s)
    remote monitoring only
    Other Intervention Name(s)
    in office monitoring
    Intervention Description
    remote monitoring only can replace in-office device monitoring
    Primary Outcome Measure Information:
    Title
    Unplanned early visits for cardiac causes1 (Patient)
    Description
    i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits
    Time Frame
    6 months
    Title
    Unplanned early visits for cardiac causes2 (Patient)
    Description
    i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits
    Time Frame
    12months
    Title
    Unplanned early visits for cardiac causes3 (Patient)
    Description
    i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits
    Time Frame
    18months
    Title
    Unplanned early visits for cardiac causes4 (Patient)
    Description
    i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits
    Time Frame
    24months
    Title
    Unplanned early visits for cardiac causes1 (Clinic)
    Description
    ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits
    Time Frame
    6months
    Title
    Unplanned early visits for cardiac causes2 (Clinic)
    Description
    ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits
    Time Frame
    12months
    Title
    Unplanned early visits for cardiac causes3 (Clinic)
    Description
    ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits
    Time Frame
    18months
    Title
    Unplanned early visits for cardiac causes4 (Clinic)
    Description
    ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits
    Time Frame
    24months
    Secondary Outcome Measure Information:
    Title
    Acute myocardial infarction (heart attack) or cerebrovascular events (stroke)
    Description
    ACS, CVA
    Time Frame
    6,12,18,24 months
    Title
    Thromboembolic events (such as pulmonary embolism)
    Description
    Systemic thromboembolic events
    Time Frame
    6,12,18,24 months
    Title
    Worsening of heart failure leading to hospitalization
    Description
    HF related admission
    Time Frame
    6,12,18,24 months
    Title
    Cardiac-related deaths
    Description
    Cardiac cause deaths
    Time Frame
    6,12,18,24 months
    Title
    Overall mortality
    Description
    overall deaths
    Time Frame
    6,12,18,24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: consented heart failure patients (LVEF<=40%) with Biotronik wireless monitoring capable ICD/CRTs aged >20 years patients who are new to remote monitoring Exclusion Criteria: For patients with a life expectancy of less than 6 months. If patient do not understand the contents of wireless monitoring or it is difficult to fill out the consent form due to cognitive decline. If wireless monitoring is performed with a patient enrolled in another clinical trial which remote monitoring may affect the previous enrolled study.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    It will not be open because its sensitive data, however, if there's reasonable request, data can be acquired after de-identification of the participants.

    Learn more about this trial

    Verifying Remote Monitoring Effect on Net Cardiovascular Outcome; RemoteVerify (RêVe)

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