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NCT Number: NCT05971225

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

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.

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Key information

Conditions

Congestive Heart Failure Cardiac Resynchronization Therapy Cardiovascular Diseases Defibrillators Heart Diseases Heart Failure

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Vincent's Hospital

Suwon, Kyonggi Do, 16247, South Korea

Location status: Recruiting

Location contact

YouMi Hwang

CONTACT

YouMi Hwang, Ph.D., M.D.

CONTACT

[email protected]

01086317220

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

remote monitoring only

Other

remote monitoring only can replace in-office device monitoring

Other names: in office monitoring

Primary outcomes

  1. Unplanned early visits for cardiac causes1 (Patient)

    Time frame: 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)

    Time frame: 12months

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

  3. Unplanned early visits for cardiac causes3 (Patient)

    Time frame: 18months

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

  4. Unplanned early visits for cardiac causes4 (Patient)

    Time frame: 24months

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

  5. Unplanned early visits for cardiac causes1 (Clinic)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 24months

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

Secondary outcomes

  1. Acute myocardial infarction (heart attack) or cerebrovascular events (stroke)

    Time frame: 6,12,18,24 months

    ACS, CVA

  2. Thromboembolic events (such as pulmonary embolism)

    Time frame: 6,12,18,24 months

    Systemic thromboembolic events

  3. Worsening of heart failure leading to hospitalization

    Time frame: 6,12,18,24 months

    HF related admission

  4. Cardiac-related deaths

    Time frame: 6,12,18,24 months

    Cardiac cause deaths

  5. Overall mortality

    Time frame: 6,12,18,24 months

    overall deaths

Sponsors and collaborators

Lead sponsor

Saint Vincent's Hospital, Korea

Other

Collaborators

  • Biotronik SE & Co. KG

Registry information

Official study 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))

Acronym: ReVe

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 2, 2023
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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