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

Not Applicable
Recruiting
Conditions
Congestive Heart Failure
Cardiac Resynchronization Therapy
Defibrillators
Registration Number
NCT05971225
Lead Sponsor
Saint Vincent's Hospital, Korea
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
450
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Unplanned early visits for cardiac causes1 (Patient)6 months

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

Unplanned early visits for cardiac causes2 (Patient)12months

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

Unplanned early visits for cardiac causes3 (Patient)18months

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

Unplanned early visits for cardiac causes4 (Patient)24months

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

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

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

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

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
NameTimeMethod
Acute myocardial infarction (heart attack) or cerebrovascular events (stroke)6,12,18,24 months

ACS, CVA

Thromboembolic events (such as pulmonary embolism)6,12,18,24 months

Systemic thromboembolic events

Worsening of heart failure leading to hospitalization6,12,18,24 months

HF related admission

Cardiac-related deaths6,12,18,24 months

Cardiac cause deaths

Overall mortality6,12,18,24 months

overall deaths

Trial Locations

Locations (1)

St. Vincent's Hospital

🇰🇷

Suwon, Kyonggi do, Korea, Republic of

St. Vincent's Hospital
🇰🇷Suwon, Kyonggi do, Korea, Republic of

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