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OpenTrials
Completed

NCT Number: NCT01691586

Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices

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.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Utrecht

Utrecht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote Patient Monitoring

Device

Remote monitoring of ICD and heart failure data

Other names: Boston Scientific LATITUDE system

In-Clinic check-ups

Other

Calender-based In-Clinic ICD check-up

Primary outcomes

  1. Patient-reported health status

    Time frame: 24 months

    23-item Kansas City Cardiomyopathy Questionnaire (KCCQ)

  2. Patient-reported device acceptance

    Time frame: 24 months

    12-item Florida Patient Acceptance Scale (FPAS)

Secondary outcomes

  1. 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

  2. Cost-effectiveness

    Time frame: 24 months

    Data regarding health care utilization is gathered from hospitals and patients.

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Boston Scientific Corporation
  • Erasmus Medical Center
  • Tilburg University

Registry information

Official study title

Remote Monitoring of Heart Failure Patients With Cardiovascular Implantable Electronic Device: The Patient Perspective

Acronym: REMOTE-CIED

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Sep 24, 2012
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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