Verifying Remote Monitoring Effect on Net Cardiovascular Outcome; RemoteVerify (RêVe)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: remote monitoring only.
- Who it may be relevant to
- Registry conditions: Congestive Heart Failure, Defibrillators, Cardiac Resynchronization Therapy. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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))
Overview
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.
Interventions
- Other remote monitoring only
remote monitoring only can replace in-office device monitoring
Primary outcome measures
- Unplanned early visits for cardiac causes1 (Patient) [Time frame: 6 months]
- Unplanned early visits for cardiac causes2 (Patient) [Time frame: 12months]
- Unplanned early visits for cardiac causes3 (Patient) [Time frame: 18months]
- Unplanned early visits for cardiac causes4 (Patient) [Time frame: 24months]
- Unplanned early visits for cardiac causes1 (Clinic) [Time frame: 6months]
- Unplanned early visits for cardiac causes2 (Clinic) [Time frame: 12months]
- Unplanned early visits for cardiac causes3 (Clinic) [Time frame: 18months]
- Unplanned early visits for cardiac causes4 (Clinic) [Time frame: 24months]
Secondary outcome measures (5)
- Acute myocardial infarction (heart attack) or cerebrovascular events (stroke) [Time frame: 6,12,18,24 months]
- Thromboembolic events (such as pulmonary embolism) [Time frame: 6,12,18,24 months]
- Worsening of heart failure leading to hospitalization [Time frame: 6,12,18,24 months]
- Cardiac-related deaths [Time frame: 6,12,18,24 months]
- Overall mortality [Time frame: 6,12,18,24 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
South Korea · 1 center
- St. Vincent's Hospital — Suwon
Identifiers
NCT: NCT05971225 · RemoteVerify