INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored Implanted Cardioverter Defibrillators (ICD) SysTems

NCT01200381 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2019-02-04

No results posted yet for this study

Summary

It's the aim of this study to analyze the benefit of personal patient / physician contacts in heart failure patients with remotely monitored implanted cardioverter defibrillators (ICD) or ICD with cardiac resynchronization therapy (CRT-D).

The personal follow up (in clinic or phone calls) will be compared to completely automatic remote follow ups.

All patients will receive remote monitoring for automatic daily alarm checks and will undergo in clinic follow ups in 12 months intervals

Conditions

Interventions

OTHER

Quarterly remote follow ups and remote monitoring

Quarterly remote follow ups and remote monitoring

OTHER

Quarterly remote follow ups + additional phone calls and remote monitoring

Quarterly remote follow ups + additional phone calls and remote monitoring

OTHER

Quarterly in clinic follow ups and remote monitoring

Quarterly in clinic follow ups and remote monitoring

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Christian Weiss, Prof. Dr. med. · Städtisches Klinikum Lüneburg gGmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Germany

Study Locations

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Entities

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 NCT01200381 on ClinicalTrials.gov