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

NCT05971225 | Recruiting DMC

• 1 other identifier: RemoteVerify
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure; Defibrillators; Cardiac Resynchronization Therapy

Keywords

remote monitoring; congestive heart failure; Defibrillators; cardiac resynchronization therapy

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (5)

• Acute myocardial infarction (heart attack) or cerebrovascular events (stroke)

  6,12,18,24 months

• Thromboembolic events (such as pulmonary embolism)

  6,12,18,24 months

• Worsening of heart failure leading to hospitalization

  6,12,18,24 months

• Cardiac-related deaths

  6,12,18,24 months

• Overall mortality

  6,12,18,24 months

Study Arms (2)

Follow up group

ACTIVE COMPARATOR

participants with experience of \>6 months in-office device interrogation, then started remote monitoring

Other: remote monitoring only

Remote group

EXPERIMENTAL

participants with newly implanted device with study agreement, and then started remote monitoring

Other: remote monitoring only

Interventions

remote monitoring only OTHER

remote monitoring only can replace in-office device monitoring

Also known as: in office monitoring

Follow up group; Remote group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saint Vincent's Hospital, Korea: lead
• Biotronik SE & Co. KG: collaborator

Study Sites (1)

St. Vincent's Hospital

Suwon, Kyonggi Do, 16247, South Korea

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: one group with experience of in-office device monitoring \>6 months the other group without experience of in-office device monitoring

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 2, 2023
• Study Start: November 11, 2023
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)