Quality of Life and Device Acceptance in Patients With ICD Undergoing Remote ICD FU

LMU Klinikum

Status: Completed

Conditions: Depression; Anxiety

Treatments: Other: Control group; Procedure: ICD remote monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT02888028

GE IDE MucM001-11

Details and patient eligibility

About

This study investigates whether an additional remote follow-up of patients with implantable cardioverter-defibrillators (ICDs) has beneficial effects on Quality of life (QoL), levels of anxiety and depression and device acceptance. Patients are randomized to either conventional in-office FU only or additional remote surveillance, follow-up duration is 12 months. The influence of other variables (age, sex,..) is evaluated regarding their influence on study endpoints.

Full description

The rising number of implantable cardiac devices leads to an increasing amount of device-related workload, e.g. regular in-office follow-ups (FU). New means of ICD FU strategies are necessary to handle the increasing burden. ICD remote monitoring promises a time- and cost efficient alternative to conventional in-office FU strategies. Many studies have already shown benefits on FU burden reduction, on saving of costs and time, and recently on total mortality. The impact of remote ICD FU on Quality of life, anxiety and depression levels and device acceptance is still under discussion. The aim of this trial is to investigate the influence of additional remote ICD surveillance on the primary endpoint health related quality of life (HRQoL), further on levels of anxiety and depression and on device acceptance.

Enrollment: 182 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients willing to participate
• Patients with new-implantation of an ICD or device replacement due to battery depletion between May 2011 and April 2013
• Sufficient knowledge of the German language
• Expectancy of life >1 years at good clinical status
• Written informed consent

Exclusion criteria

• Age <18 years
• Subjects not able to give written informed consent
• Subjects without sufficient German language skills

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

ICD remote monitoring

Active Comparator group

Description:

Active Comparator: ICD remote monitoring additionally to regular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement

Treatment:

Procedure: ICD remote monitoring

Control group

Other group

Description:

Regular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement w/o remote FU

Treatment:

Other: Control group