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

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))

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.

Study Overview

• Status: Recruiting
• Conditions: Congestive Heart Failure; Cardiac Resynchronization Therapy; Defibrillators
• Intervention / Treatment: Other: remote monitoring only

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyonggi Do
    • Suwon, Kyonggi Do, Korea, Republic of, 16247
      • Recruiting
      • St. Vincent's Hospital
      • Contact: YouMi Hwang, Ph.D., M.D.; Phone Number: 01086317220; Email: youmi0607@naver.com
      • Principal Investigator: YouMi Hwang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Follow up group; participants with experience of >6 months in-office device interrogation, then started remote monitoring	Other: remote monitoring only; remote monitoring only can replace in-office device monitoring; Other Names: in office monitoring
Experimental: Remote group; participants with newly implanted device with study agreement, and then started remote monitoring	Other: remote monitoring only; remote monitoring only can replace in-office device monitoring; Other Names: in office monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unplanned early visits for cardiac causes1 (Patient)	i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits	6 months
Unplanned early visits for cardiac causes2 (Patient)	i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits	12months
Unplanned early visits for cardiac causes3 (Patient)	i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits	18months
Unplanned early visits for cardiac causes4 (Patient)	i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits	24months
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
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
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Saint Vincent's Hospital, Korea
• Collaborators: Biotronik SE & Co. KG

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2023
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: cardiac resynchronization therapy; remote monitoring; congestive heart failure; Defibrillators
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: RemoteVerify

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It will not be open because its sensitive data, however, if there's reasonable request, data can be acquired after de-identification of the participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No