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).

Study Overview

• Status: Recruiting
• Conditions: Patients With Defibrillator
• Intervention / Treatment: Device: on remote monitoring

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 1140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Taehoon Kim; Phone Number: +82 02-2228-8460; Email: thkimcardio@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Severance Hospital, Yonsei University Health System
    • Contact: Taehoon Kim; Phone Number: +82 02-2228-8460; Email: thkimcardio@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. All ICD and CRT-D patients who are over the age of 18
2. Ability to provide informed consent and to complete the study and required follow-up

Exclusion Criteria:

1. Those who refuse to participate in the trial.
2. Those who refuse to use remote monitoring system or who live in an environment where remote monitoring system cannot be utilized.
3. Patient who refuse to use or expected to use less than 75% of remote monitoring system.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote Monitoring follow up; This 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	Device: on remote monitoring; This 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
No Intervention: Conventional Follow up; This group will not turn on remote monitoring function of defibrillator. Patient should be seen at clinic according to center's custom but no longer than 6 months between each visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse event	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	up to 2 years
Major adverse event, including death from any cause, cardiovascular, and procedure- or device-related MAE.	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.	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Economic benefit by remote monitoring	- Cost Incurred by the patient towards the transportation	up to 2 years
Economic benefit by remote monitoring	- Consultation fee	up to 2 years
Economic benefit by remote monitoring	- Patient Travel Time	up to 2 years
Economic benefit by remote monitoring	- Patient consultation Time	up to 2 years
Economic benefit by remote monitoring	- Administrative activities Time	up to 2 years
Economic benefit by remote monitoring	- Device interrogation Time	up to 2 years
Economic benefit by remotemonitoring	- Cost towards loss of employment for time spent in hospital for check-up of patient	up to 2 years
Economic benefit by remotemonitoring	- Cost towards loss of employment of attendant for time spent in hospital for check-up of patient (dependent)	up to 2 years

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2020
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: October 24, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: defibrillator; clinical; remote monitoring; economic; benefit
• Other Study ID Numbers: 1-2020-0075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No