NCT01691586

Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices

Remote Monitoring of Heart Failure Patients With Cardiovascular Implantable Electronic Device: The Patient Perspective

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A relatively new and promising development in the area of cardiovascular implantable electronic device therapy is remote patient monitoring (RPM). RPM systems can interrogate the device automatically and send the data from the patients' home to the physician, thereby reducing in-clinic follow-ups. The purpose of this study is to evaluate the effect of RPM + in-clinic follow-up versus in-clinic follow-up only on patient-reported health status and device-acceptance after implantation with an implantable cardioverter defibrillator (ICD) or cardiac resynchronization defibrillator (CRT-D). Secondary objectives are (1) to identify subgroups of patients who prefer RPM over in-clinic visits or vice versa due to specific clinical and psychological factors and (2) To investigate the cost-effectiveness of RPM + in-clinic follow-up compared to in-clinic follow-up only.

Conditions

• Congestive Heart Failure

Interventions

Type	Name	Description
DEVICE	Remote patient monitoring	Remote monitoring of ICD and heart failure data
OTHER	In-Clinic check-ups	Calender-based In-Clinic ICD check-up

Timeline

• Start date: 2013-04-13
• Primary completion: 2018-01-15
• Completion: 2018-01-15
• First posted: 2012-09-24
• Last updated: 2018-06-08

Locations

1 site across 1 country: Netherlands