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

NCT02888028 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2018-06-21

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Klinikum Bielefeld

    collaborator OTHER

  • LMU Klinikum

    lead OTHER

Principal Investigators

  • Johannes Siebermair, MD · Munich University Clinic, Campus Grosshadern, Munich, Germany

  • Florian Leppert, MSc · Bielefeld University, School of public health Bielefeld, Germany

  • Stefan Kääb, MD · Munich University Clinic, Campus Grosshadern, Munich, Germany

  • Wolfgang Greiner, MD · Bielefeld University, School of public health, Bielefeld, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-04-30
Completion
2014-06-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02888028 on ClinicalTrials.gov