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Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices

NCT01691586 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2018-06-08

No results posted yet for this study

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

DEVICE

Remote patient monitoring

Remote monitoring of ICD and heart failure data

OTHER

In-Clinic check-ups

Calender-based In-Clinic ICD check-up

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Tilburg University

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Mathias Meine, MD, PhD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-13
Primary Completion
2018-01-15
Completion
2018-01-15

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01691586 on ClinicalTrials.gov