Status:

RECRUITING

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

Lead Sponsor:

Saint Vincent's Hospital, Korea

Collaborating Sponsors:

Biotronik SE & Co. KG

Conditions:

Congestive Heart Failure

Defibrillators

Eligibility:

All Genders

20+ years

Phase:

NA

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 unplan...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

November 11 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 30 2027

Estimated Enrollment :

450 Patients enrolled

Trial Details

Trial ID

NCT05971225

Start Date

November 11 2023

End Date

April 30 2027

Last Update

December 3 2024

Active Locations (1)

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1

St. Vincent's Hospital

Suwon, Kyonggi Do, South Korea, 16247