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

Inclusion Criteria2

  • consented heart failure patients (LVEF\<=40%) with Biotronik wireless monitoring capable ICD/CRTs aged \>20 years
  • patients who are new to remote monitoring

Exclusion Criteria2

  • 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.

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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