NCT02888028

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

Quality of Life and Device Acceptance in Patients With Implantable Cardioverter-defibrillators Undergoing Remote ICD Follow-up

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: LMU Klinikum · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Anxiety
• Depression

Interventions

Type	Name	Description
PROCEDURE	ICD remote monitoring	ICD remote monitoring additionally to regular in-office visits
OTHER	Control group	Regular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement w/o remote FU

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-04-01
• Completion: 2014-06-01
• First posted: 2016-09-02
• Last updated: 2018-06-21

Locations

2 sites across 1 country: Germany