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

Congestive Heart Failure Clinical Trial

— ReVe  

Official title:

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))

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05971225
• Other study ID #: RemoteVerify
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2023
• Est. completion date: April 30, 2027

Study information

• Verified date: July 2023
• Source: Saint Vincent's Hospital, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: April 30, 2027
• Est. primary completion date: October 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy
• Congestive Heart Failure
• Defibrillators
• Heart Failure

Intervention

Other:
• remote monitoring only
remote monitoring only can replace in-office device monitoring

Locations

Country	Name	City	State
Korea, Republic of	St. Vincent's Hospital	Suwon	Kyonggi Do

Sponsors (2)

Lead Sponsor	Collaborator
Saint Vincent's Hospital, Korea	Biotronik SE & Co. KG

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unplanned early visits for cardiac causes1 (Patient)	i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits	6 months
Primary	Unplanned early visits for cardiac causes2 (Patient)	i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits	12months
Primary	Unplanned early visits for cardiac causes3 (Patient)	i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits	18months
Primary	Unplanned early visits for cardiac causes4 (Patient)	i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits	24months
Primary	Unplanned early visits for cardiac causes1 (Clinic)	ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits	6months
Primary	Unplanned early visits for cardiac causes2 (Clinic)	ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits	12months
Primary	Unplanned early visits for cardiac causes3 (Clinic)	ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits	18months
Primary	Unplanned early visits for cardiac causes4 (Clinic)	ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits	24months
Secondary	Acute myocardial infarction (heart attack) or cerebrovascular events (stroke)	ACS, CVA	6,12,18,24 months
Secondary	Thromboembolic events (such as pulmonary embolism)	Systemic thromboembolic events	6,12,18,24 months
Secondary	Worsening of heart failure leading to hospitalization	HF related admission	6,12,18,24 months
Secondary	Cardiac-related deaths	Cardiac cause deaths	6,12,18,24 months
Secondary	Overall mortality	overall deaths	6,12,18,24 months