Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-13

Study Completion Date

2018-01-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Remote patient management

Remote patient management system + yearly in-clinic follow-up

Group Type EXPERIMENTAL

Remote patient monitoring

Intervention Type DEVICE

Remote monitoring of ICD and heart failure data

In-Clinic check-ups

Intervention Type OTHER

Calender-based In-Clinic ICD check-up

In-Clinic follow-up

In-clinic follow-up according to standard practice (every 3-6 months)

Group Type OTHER

In-Clinic check-ups

Intervention Type OTHER

Calender-based In-Clinic ICD check-up

Interventions

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Remote patient monitoring

Remote monitoring of ICD and heart failure data

Intervention Type DEVICE

In-Clinic check-ups

Calender-based In-Clinic ICD check-up

Intervention Type OTHER

Other Intervention Names

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Boston Scientific LATITUDE system

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No