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

Not Applicable

Recruiting

• Conditions: Congestive Heart Failure; Cardiac Resynchronization Therapy; Defibrillators

• Registration Number: NCT05971225
• Lead Sponsor: Saint Vincent's Hospital, Korea

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-13
• Study First Submitted QC: 2023-07-24
• Study First Posted: 2023-08-02
• Study Start: 2023-11-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-03
• Primary Completion: 2026-10-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Unplanned early visits for cardiac causes1 (Patient)	6 months	i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits
Unplanned early visits for cardiac causes2 (Patient)	12months	i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits
Unplanned early visits for cardiac causes3 (Patient)	18months	i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits
Unplanned early visits for cardiac causes4 (Patient)	24months	i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits
Unplanned early visits for cardiac causes1 (Clinic)	6months	ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -\> Clinician-driven early visits
Unplanned early visits for cardiac causes2 (Clinic)	12months	ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -\> Clinician-driven early visits
Unplanned early visits for cardiac causes3 (Clinic)	18months	ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -\> Clinician-driven early visits
Unplanned early visits for cardiac causes4 (Clinic)	24months	ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -\> Clinician-driven early visits

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St. Vincent's Hospital; 🇰🇷 Suwon, Kyonggi do, Korea, Republic of