Remote Monitoring of Heart Failure Patients with a Cardiovascular Implantable Electronic Device: The Patient Perspective (REMOTE-CIED study)

Completed

• Conditions: heart failure; 10019280

• Registration Number: NL-OMON44924
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 347

Inclusion Criteria

-First time ICD or CRT-D implanted at one of the participating centers
-LVEF * 35% (assessed max. 12 months prior to implantation)
-NYHA functional class II or III symptoms at time of implantation
-ICD/CRT-D device compatible with the LATITUDE® Patient Management system from Boston Scientific (e.g., COGNIS®)

Exclusion Criteria

-Younger than 18 or older than 85 years of age
-On the waiting list for heart transplantation
-History of psychiatric illness other than affective/anxiety disorders
-Inability to fill out the questionnaires due to cognitive impairments (e.g. dementia)
-Insufficient knowledge of the language to fill in the questionnaires

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary:<br /><br>disease-specific health status, device acceptance</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary:<br /><br>1) satisfaction with RPM<br /><br>2) cost-effectiveness.</p><br>