AzTrials
AzTrials

Congestive Heart FailureReVeNCT05971225

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

A study testing remote monitoring only in people with Congestive Heart Failure and Defibrillators, run by Saint Vincent's Hospital, Korea at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
remote monitoring only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
1 siteSouth Korea
Study dates
11 Nov 2023to 30 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site, 1 recruiting

  • St. Vincent's Hospital

    Suwon, Kyonggi Do, 16247

    YouMi Hwang, Ph.D., M.D., 01086317220, youmi0607@naver.com

    YouMi Hwang

    Recruiting

Other trials in South Korea

About this study

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))

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.

Being tested
remote monitoring only
Keywords
remote monitoring, congestive heart failure, Defibrillators, cardiac resynchronization therapy
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • remote monitoring onlyOther

    Also called in office monitoring

    remote monitoring only can replace in-office device monitoring

Study groups in NCT05971225
Study groupRoleWhat they receive
Follow up groupActive comparatorparticipants with experience of >6 months in-office device interrogation, then started remote monitoring
Receives: Other: remote monitoring only
Remote groupExperimentalparticipants with newly implanted device with study agreement, and then started remote monitoring
Receives: Other: remote monitoring only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Unplanned early visits for cardiac causes1 (Patient)

    1. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits

    Measured: 6 months

  2. Unplanned early visits for cardiac causes2 (Patient)

    1. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits

    Measured: 12months

  3. Unplanned early visits for cardiac causes3 (Patient)

    1. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits

    Measured: 18months

  4. Unplanned early visits for cardiac causes4 (Patient)

    1. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits

    Measured: 24months

  5. 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

    Measured: 6months

  6. 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

    Measured: 12months

  7. 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

    Measured: 18months

  8. 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

    Measured: 24months

Secondary outcomes (5)

  1. Acute myocardial infarction (heart attack) or cerebrovascular events (stroke)

    ACS, CVA

    Measured: 6,12,18,24 months

  2. Thromboembolic events (such as pulmonary embolism)

    Systemic thromboembolic events

    Measured: 6,12,18,24 months

  3. Worsening of heart failure leading to hospitalization

    HF related admission

    Measured: 6,12,18,24 months

  4. Cardiac-related deaths

    Cardiac cause deaths

    Measured: 6,12,18,24 months

  5. Overall mortality

    overall deaths

    Measured: 6,12,18,24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2023
  2. Study start11 Nov 2023
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
one group with experience of in-office device monitoring \>6 months the other group without experience of in-office device monitoring
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05971225
Sponsor's protocol ID
RemoteVerify
Acronym
ReVe
Status last verified
Nov 2024
First submitted
13 Jul 2023
Last updated
3 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing remote monitoring only in people with Congestive Heart Failure and Defibrillators, run by Saint Vincent's Hospital, Korea at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unplanned early visits for cardiac causes1 (Patient) (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05971225.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in