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

Sponsor
Saint Vincent's Hospital, Korea (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05971225
Collaborator
Biotronik SE & Co. KG (Industry)
450
Enrollment
2
Arms
42.9
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: remote monitoring only
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
450 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
one group with experience of in-office device monitoring >6 months the other group without experience of in-office device monitoringone group with experience of in-office device monitoring >6 months the other group without experience of in-office device monitoring
Masking:
None (Open Label)
Primary Purpose:
Prevention
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))
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 30, 2026
Anticipated Study Completion Date :
Apr 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Follow up group

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

Other: remote monitoring only
remote monitoring only can replace in-office device monitoring
Other Names:
  • in office monitoring

    		•
    Experimental: Remote group

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

    Other: remote monitoring only
    remote monitoring only can replace in-office device monitoring
    Other Names:
  • in office monitoring

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Unplanned early visits for cardiac causes1 (Patient) [6 months]

      i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits

    2. Unplanned early visits for cardiac causes2 (Patient) [12months]

      i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits

    3. Unplanned early visits for cardiac causes3 (Patient) [18months]

      i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits

    4. Unplanned early visits for cardiac causes4 (Patient) [24months]

      i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits

    5. Unplanned early visits for cardiac causes1 (Clinic) [6months]

      ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits

    6. Unplanned early visits for cardiac causes2 (Clinic) [12months]

      ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits

    7. Unplanned early visits for cardiac causes3 (Clinic) [18months]

      ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits

    8. Unplanned early visits for cardiac causes4 (Clinic) [24months]

      ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits

    Secondary Outcome Measures

    1. Acute myocardial infarction (heart attack) or cerebrovascular events (stroke) [6,12,18,24 months]

      ACS, CVA

    2. Thromboembolic events (such as pulmonary embolism) [6,12,18,24 months]

      Systemic thromboembolic events

    3. Worsening of heart failure leading to hospitalization [6,12,18,24 months]

      HF related admission

    4. Cardiac-related deaths [6,12,18,24 months]

      Cardiac cause deaths

    5. Overall mortality [6,12,18,24 months]

      overall deaths

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Saint Vincent's Hospital, Korea
    • Biotronik SE & Co. KG

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Saint Vincent's Hospital, Korea
    ClinicalTrials.gov Identifier:
    NCT05971225
    Other Study ID Numbers:
    • RemoteVerify
    First Posted:
    Aug 2, 2023
    Last Update Posted:
    Aug 2, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Saint Vincent's Hospital, Korea
    remote monitoring
    congestive heart failure
    Defibrillators
    cardiac resynchronization therapy
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Aug 2, 2023