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

Study Overview
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Brief Summary
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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.

Official Title
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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))

Conditions
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Congestive Heart Failure, Defibrillators, Cardiac Resynchronization Therapy

Intervention / Treatment
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* Other: remote monitoring only


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Follow up group<br>participants with experience of >6 months in-office device interrogation, then started remote monitoring | Other: remote monitoring only<br>* remote monitoring only can replace in-office device monitoring<br>* Other names: in office monitoring;|
| Experimental: Remote group<br>participants with newly implanted device with study agreement, and then started remote monitoring | Other: remote monitoring only<br>* remote monitoring only can replace in-office device monitoring<br>* Other names: in office monitoring;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unplanned early visits for cardiac causes1 (Patient) | i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits | 6 months | 
| Unplanned early visits for cardiac causes2 (Patient) | i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits | 12months | 
| Unplanned early visits for cardiac causes3 (Patient) | i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits | 18months | 
| Unplanned early visits for cardiac causes4 (Patient) | i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits | 24months | 
| 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 | 6months | 
| 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 | 12months | 
| 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 | 18months | 
| 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 | 24months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute myocardial infarction (heart attack) or cerebrovascular events (stroke) | ACS, CVA | 6,12,18,24 months | 
| Thromboembolic events (such as pulmonary embolism) | Systemic thromboembolic events | 6,12,18,24 months | 
| Worsening of heart failure leading to hospitalization | HF related admission | 6,12,18,24 months | 
| Cardiac-related deaths | Cardiac cause deaths | 6,12,18,24 months | 
| Overall mortality | overall deaths | 6,12,18,24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remote monitoring, congestive heart failure, Defibrillators, cardiac resynchronization therapy