Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices (REMOTE-CIED)

UMC Utrecht

Status: Completed

Conditions: Congestive Heart Failure

Treatments: Device: Remote patient monitoring; Other: In-Clinic check-ups

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01691586

UMCU.DHL.001

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• first time ICD/CRT-D implanted at one of the participating centers
• left ventricular ejection fraction <35%
• NYHA functional class II or III symptoms
• ICD/CRT-D device compatible with the LATITUDE(r) RPM system from Boston Scientific

Exclusion criteria

• On the waiting list for heart transplantation
• History of psychiatric illness others than affective/anxiety disorders
• Cognitive impairments
• Insufficient knowledge of the language to fill in the questionnaires

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Remote patient management

Experimental group

Description:

Remote patient management system + yearly in-clinic follow-up

Treatment:

Other: In-Clinic check-ups

Device: Remote patient monitoring

In-Clinic follow-up

Other group

Description:

In-clinic follow-up according to standard practice (every 3-6 months)

Treatment:

Other: In-Clinic check-ups