Cost-effectiveness Analysis on Remote Monitoring for CIEDs in Japan by Using Systematic Review Methodology

NCT03747809 | Completed FDA Device

• 1 other identifier: OUJ11200212018111801
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

2018 Revision of Health Reimbursement in Japan recognized non face-to-face diagnostics, such as Online Treatment, as the standard of care. There was a significantly additional cost for Cardiovascular Implantable Electronic Devices (CIEDs) Management Fee as well. The adaption of Remote Monitoring for CIEDs patients is recommended by the societies based on the clinical evidences. However, how QALYs earned by CIEDs Remote Monitoring are justified in Japanese reimbursement environment from the cost-effectiveness standpoint is still not so clear. The evaluation about the impact on the health economics about the installation of CIEDs Remote Monitoring has not been enough due to the lack of the researches around this field. Therefore this research is designed to examine the impact of the installation of CIEDs Remote Monitoring from the health economics perspective by considering the health insurance system and the clinical process in Japan, through Systematic Review methodology.

Conditions

Cardiovascular Diseases; Heart Failure

Keywords

Remote Monitoring

Outcome Measures

Primary Outcomes (1)

• Differences of ICERs based on earned QALYs from selected studies by applying to Japanese reimbursement environment.

  12 months

Study Arms (2)

Patients with CIEDs having Remote Monitoring

Device: CIEDs Remote Monitoring System

Patients with CIEDs having no Remote Monitoring

Interventions

CIEDs Remote Monitoring System DEVICE

Cardiac device remote monitoring system

Patients with CIEDs having Remote Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults implanted with CIEDs such as Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy, or Pacemaker

You may qualify if:

• Studies that involves CIEDs Remote Monitoring, such as Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy, and Pacemaker
• Follow-up periods more than or equal to 12 months
• Prospective studies
• QALYs available to make ICER analysis possible
• Published after Year of 1971

You may not qualify if:

• Studies that are not related with CIEDs
• Follow-up periods less than 12 months
• Not prospective studies
• QALYs unavailable
• Published before Year or 1971

Sponsors & Collaborators

• The Open University of Japan: lead

Study Sites (1)

The Open University of Japan

Chiba, Japan

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2018
• First Posted: November 20, 2018
• Study Start: September 1, 2018
• Primary Completion: June 16, 2019
• Study Completion: June 16, 2019
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

JP (1)