Overview

This trial is active, not recruiting.

Condition congestive heart failure
Sponsor UMC Utrecht
Collaborator Boston Scientific Corporation
Start date April 2013
End date December 2017
Trial size 600 participants
Trial identifier NCT01691586, UMCU.DHL.001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
Remote patient management system + yearly in-clinic follow-up
In-clinic follow-up according to standard practice (every 3-6 months)

Primary Outcomes

Measure
Patient-reported health status
time frame: 24 months
Patient-reported device acceptance
time frame: 24 months

Secondary Outcomes

Measure
Patient-reported satisfaction with care
time frame: 24 months
Cost-effectiveness
time frame: 24 months

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Remote Monitoring of Heart Failure Patients With Cardiovascular Implantable Electronic Device: The Patient Perspective
Principal investigator Mathias Meine, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by UMC Utrecht.