Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by UMC Utrecht
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: August 19, 2014
Last verified: August 2014

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 UMC Utrecht:

Primary Outcome Measures:
  • Patient-reported health status [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    23-item Kansas City Cardiomyopathy Questionnaire (KCCQ)

  • Patient-reported device acceptance [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    12-item Florida Patient Acceptance Scale (FPAS)

Secondary Outcome Measures:
  • Patient-reported satisfaction with care [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    Data regarding health care utilization is gathered from hospitals and patients.

Estimated Enrollment: 900
Study Start Date: April 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
RPM + in-clinic follow-up
In-clinic follow-up


Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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

Contact: Mathias Meine, Dr +31 (0)88 466 6184

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

No publications provided

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: August 19, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
implantable defibrillators
remote patient monitoring
patient-reported outcomes

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases processed this record on November 25, 2014