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

Saint Vincent's Hospital, Korea

Status: Enrolling

Conditions: Defibrillators; Cardiac Resynchronization Therapy; Congestive Heart Failure

Treatments: Other: remote monitoring only

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05971225

RemoteVerify

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

Follow up group

Active Comparator group

Description:

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

Treatment:

Other: remote monitoring only

Remote group

Experimental group

Description:

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

Treatment:

Other: remote monitoring only