Severance Hospital, Yonsei University Health System
Seoul, South Korea
Location status: Recruiting
Recruiting
NCT Number: NCT05106062
Economic and Clinical Benefit of Remote Monitoring Among Defibrillator Patients by Indication Subgroups (BENEFIT-RM)
Remote monitoring is now universally available for all cardiac implantable electronic devices (CIEDs), and it has become the standard of care for the management of patients with these devices. In many countries, it is being proven that patients with implantable defibrillator (ICD) or cardiac resynchronizing therapy (CRT) can benefit from remote monitoring (RM) both economically and clinically. From previous RM related clinical studies, it is reasonably accepted that hospitalization cost and mortality rate is comparably higher in defibrillator patients compared to pacemaker indicated patients.
However, it is yet to be discovered which group of defibrillator patients are the most beneficiaries using remote monitoring system. In this study, the investigators would further categorize defibrillator patients into different indication subgroups and compare both economic and clinical benefits among different indication. By comparing economic and clinical benefits of remote monitoring by different subgroups, the investigators might be able to set a guideline on which group of patients should be strongly suggested for remote monitoring utilization.
Therefore, the investigators perform a prospective study in Korean population to compare economic and clinical benefits of RM compared to conventional follow-up in overall study cohort and by different subgroups. (ICD & CRT-D).
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
19 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
The investigators propose to prospectively recruit 556 patients with ICD or CRT-D implantation in 10 sites in Korea.
- Eligible patients should be enrolled in remote monitoring system 0 to 45 days after successful device implantation and then randomly assigned in a 1:1 ratio to the RM or conventional follow-up group.
- In the RM follow-up arm, the patients are not mandated to visit the clinic unless there is unscheduled call due to adverse event notification.
- In the conventional follow-up arm, the patients should be seen at the clinic according to each center's custom but no longer than 1 year between each visit. Follow-up should be continued accordingly until two-years of device implant.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- All ICD and CRT-D patients who are over the age of 18
- Ability to provide informed consent and to complete the study and required follow-up
Exclusion criteria
- Those who refuse to participate in the trial.
- Those who refuse to use remote monitoring system or who live in an environment where remote monitoring system cannot be utilized.
- Patient who refuse to use or expected to use less than 75% of remote monitoring system.
Treatment and study plan
on remote monitoring
DeviceThis group will turn on the RM function 0 to 45 days after defibrillator implantation. Patient should be seen at clinic once a year, or if there is any adverse event notification
Primary outcomes
-
Major adverse event
Time frame: up to 2 years
Definition of major adverse events (MAE)
- fatal or life-threatening
- prompted or prolonged a hospitalization;
- caused major or permanent disability or injury;
- required an intervention to prevent permanent disability or injury
-
Major adverse event, including death from any cause, cardiovascular, and procedure- or device-related MAE.
Time frame: up to 2 years
Definition of device-related adverse events
- delivery of ≥1 inappropriate shock(s);
- delivery of ≥2 symptomatic inappropriate ATP;
- symptomatic defibrillator-mediated tachycardia;
- infection or extrusion of the ICD;
- ineffective pacing;
- intermittent or permanent undersensing;
- clinical phrenic stimulation; and
- lead or pulse generator dysfunction.
Secondary outcomes
-
Economic benefit by remote monitoring
Time frame: up to 2 years
- Cost Incurred by the patient towards the transportation
-
Economic benefit by remote monitoring
Time frame: up to 2 years
- Consultation fee
-
Economic benefit by remote monitoring
Time frame: up to 2 years
- Patient Travel Time
-
Economic benefit by remote monitoring
Time frame: up to 2 years
- Patient consultation Time
-
Economic benefit by remote monitoring
Time frame: up to 2 years
- Administrative activities Time
-
Economic benefit by remote monitoring
Time frame: up to 2 years
- Device interrogation Time
-
Economic benefit by remotemonitoring
Time frame: up to 2 years
- Cost towards loss of employment for time spent in hospital for check-up of patient
-
Economic benefit by remotemonitoring
Time frame: up to 2 years
- Cost towards loss of employment of attendant for time spent in hospital for check-up of patient (dependent)
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Yonsei University
Other
Registry information
Important dates
- Study start
- 2020
- Primary completion
- 2029
- Study completion
- 2029
- First posted
- Nov 3, 2021
- Registry last updated
- Aug 23, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.