Clinical trial NCT05971225: Verifying Remote Monitoring Effect on Net Cardiovascular Outcome; RemoteVerify (RêVe)
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))
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congestive Heart Failure
Defibrillators
Cardiac Resynchronization Therapy
Keywords: remote monitoring
congestive heart failure
Defibrillators
cardiac resynchronization therapy
Lead sponsor: Saint Vincent's Hospital, Korea
Sponsor class: OTHER
Collaborators: name: Biotronik SE & Co. KG
First posted: 2023-08-02
Enrollment: 450
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one group with experience of in-office device monitoring \>6 months the other group without experience of in-office device monitoring
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Unplanned early visits for cardiac causes1 (Patient)
timeFrame: 6 months
measure: Unplanned early visits for cardiac causes2 (Patient)
timeFrame: 12months
measure: Unplanned early visits for cardiac causes3 (Patient)
timeFrame: 18months
measure: Unplanned early visits for cardiac causes4 (Patient)
timeFrame: 24months
measure: Unplanned early visits for cardiac causes1 (Clinic)
timeFrame: 6months
measure: Unplanned early visits for cardiac causes2 (Clinic)
timeFrame: 12months
measure: Unplanned early visits for cardiac causes3 (Clinic)
timeFrame: 18months
measure: Unplanned early visits for cardiac causes4 (Clinic)
timeFrame: 24months
Secondary outcomes:
measure: Acute myocardial infarction (heart attack) or cerebrovascular events (stroke)
timeFrame: 6,12,18,24 months
measure: Thromboembolic events (such as pulmonary embolism)
timeFrame: 6,12,18,24 months
measure: Worsening of heart failure leading to hospitalization
timeFrame: 6,12,18,24 months
measure: Cardiac-related deaths
timeFrame: 6,12,18,24 months
measure: Overall mortality
timeFrame: 6,12,18,24 months
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: St. Vincent's Hospital
state: Kyonggi do
Study officials:
References: