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

This study is ongoing, but not recruiting participants.
Boston Scientific Corporation
University of Tilburg
Erasmus Medical Center
Information provided by (Responsible Party):
M. Meine, UMC Utrecht Identifier:
First received: September 20, 2012
Last updated: May 19, 2016
Last verified: May 2016

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.

Congestive Heart Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Remote Monitoring of Heart Failure Patients With Cardiovascular Implantable Electronic Device: The Patient Perspective

Resource links provided by NLM:

Further study details as provided by M. Meine, UMC Utrecht:

Primary Outcome Measures:
  • Patient-reported health status [ Time Frame: 24 months ]
    23-item Kansas City Cardiomyopathy Questionnaire (KCCQ)

  • Patient-reported device acceptance [ Time Frame: 24 months ]
    12-item Florida Patient Acceptance Scale (FPAS)

Secondary Outcome Measures:
  • Patient-reported satisfaction with care [ Time Frame: 24 months ]
    • Visual Analogue Scale ranging from 0-100 (with higher score representing more satisfaction with care)
    • 26-item self-made questionnaire to assess satisfaction with RPM

  • Cost-effectiveness [ Time Frame: 24 months ]
    Data regarding health care utilization is gathered from hospitals and patients.

Enrollment: 600
Study Start Date: April 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Remote patient management system + yearly in-clinic follow-up
In-clinic follow-up according to standard practice (every 3-6 months)


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Heart failure patients implanted with a first-time ICD/CRT-D device at one of the participating centers.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01691586

University Medical Center Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
UMC Utrecht
Boston Scientific Corporation
University of Tilburg
Erasmus Medical Center
Principal Investigator: Mathias Meine, MD, PhD UMC Utrecht
  More Information

Responsible Party: M. Meine, Principal Investigator, UMC Utrecht Identifier: NCT01691586     History of Changes
Other Study ID Numbers: UMCU.DHL.001
Study First Received: September 20, 2012
Last Updated: May 19, 2016

Keywords provided by M. Meine, UMC Utrecht:
implantable defibrillators
remote patient monitoring
patient-reported outcomes

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on August 18, 2017