RecruitingNot ApplicableNCT05971225

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

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))


Sponsor

Saint Vincent's Hospital, Korea

Enrollment

450 participants

Start Date

Nov 11, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study (called RêVe — RemoteVerify) is investigating whether remote cardiac monitoring (having your heart device automatically send data to your doctor wirelessly) reduces deaths and hospitalizations compared to standard in-clinic monitoring in people with heart failure who have an implanted defibrillator or cardiac resynchronization device. Remote monitoring is already used widely, but this trial aims to provide definitive clinical evidence of its benefit. **You may be eligible if...** - You have heart failure with a significantly reduced pumping function (LVEF of 40% or less) - You have a Biotronik wireless-capable implanted defibrillator (ICD) or cardiac resynchronization therapy device (CRT) - You are new to remote monitoring (have not used it before) - You are over 20 years old and have given informed consent **You may NOT be eligible if...** - Your life expectancy is less than 6 months - You have significant cognitive decline that prevents you from understanding the monitoring system or signing consent - You are enrolled in another clinical trial where remote monitoring could affect results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERremote monitoring only

remote monitoring only can replace in-office device monitoring


Locations(1)

St. Vincent's Hospital

Suwon, Kyonggi Do, South Korea

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NCT05971225


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