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

NCT ID: NCT05971225

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-11

Study Completion Date

2027-04-30

Brief Summary

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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

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Conditions

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Congestive Heart Failure Defibrillators Cardiac Resynchronization Therapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

one group with experience of in-office device monitoring \>6 months the other group without experience of in-office device monitoring
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Follow up group

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

Group Type ACTIVE_COMPARATOR

remote monitoring only

Intervention Type OTHER

remote monitoring only can replace in-office device monitoring

Remote group

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

Group Type EXPERIMENTAL

remote monitoring only

Intervention Type OTHER

remote monitoring only can replace in-office device monitoring

Interventions

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remote monitoring only

remote monitoring only can replace in-office device monitoring

Intervention Type OTHER

Other Intervention Names

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in office monitoring

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biotronik SE & Co. KG

INDUSTRY

Sponsor Role collaborator

Saint Vincent's Hospital, Korea

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St. Vincent's Hospital

Suwon, Kyonggi Do, South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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YouMi Hwang, Ph.D., M.D.

Role: primary

[email protected]
01086317220

YouMi Hwang

Role: backup

Other Identifiers

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RemoteVerify

Identifier Type: -

Identifier Source: org_study_id