Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices (REMOTE-CIED)
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ClinicalTrials.gov Identifier: NCT01691586 |
Recruitment Status :
Completed
First Posted : September 24, 2012
Last Update Posted : June 8, 2018
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Congestive Heart Failure | Device: Remote patient monitoring Other: In-Clinic check-ups | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 600 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Remote Monitoring of Heart Failure Patients With Cardiovascular Implantable Electronic Device: The Patient Perspective |
Actual Study Start Date : | April 13, 2013 |
Actual Primary Completion Date : | January 15, 2018 |
Actual Study Completion Date : | January 15, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Remote patient management
Remote patient management system + yearly in-clinic follow-up
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Device: Remote patient monitoring
Remote monitoring of ICD and heart failure data
Other Name: Boston Scientific LATITUDE system Other: In-Clinic check-ups Calender-based In-Clinic ICD check-up |
In-Clinic follow-up
In-clinic follow-up according to standard practice (every 3-6 months)
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Other: In-Clinic check-ups
Calender-based In-Clinic ICD check-up |
- 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)
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691586
Netherlands | |
University Medical Center Utrecht | |
Utrecht, Netherlands |
Principal Investigator: | Mathias Meine, MD, PhD | UMC Utrecht |
Responsible Party: | M. Meine, Principal Investigator, UMC Utrecht |
ClinicalTrials.gov Identifier: | NCT01691586 |
Other Study ID Numbers: |
UMCU.DHL.001 |
First Posted: | September 24, 2012 Key Record Dates |
Last Update Posted: | June 8, 2018 |
Last Verified: | June 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
implantable defibrillators remote patient monitoring patient-reported outcomes cost-effectiveness |
Heart Failure Heart Diseases Cardiovascular Diseases |