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

February 1, 2019 updated by: Abbott Medical Devices

INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored ICD SysTems

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Friedrichshall, Germany, 74177
        • SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
      • Bad Oldesloe, Germany, 23843
        • Asklepios Klinik Bad Oldesloe
      • Bad Segeberg, Germany, 23795
        • Segeberger Kliniken GmbH
      • Bielefeld, Germany, 33617
        • Evangelisches Krankenhaus Bielefeld gGmbH
      • Essen, Germany, 45122
        • Universitatsklinikum Essen (Aor)
      • Göttingen, Germany, 37073
        • Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH
      • Hamburg, Germany, 20099
        • Asklepios Klinik St. Georg
      • Hamburg, Germany, 22307
        • Asklepios Klinik Barmbek
      • Ingolstadt, Germany, 85049
        • Klinikum Ingolstadt GmbH
      • Köln, Germany, 51103
        • Evangelisches Krankenhaus Kalk
      • Ludwigsburg, Germany, 71634
        • Kardiologische Praxis - Partnergesellschaft
      • Lüneburg, Germany, 21339
        • Städtisches Klinikum Lüneburg gGmbH
      • Neuwied, Germany, 56564
        • Marienhaus Klinikum St. Elisabeth-Krankenhaus
      • Nürtingen, Germany, 72622
        • Praxis Dr. med. Balbach / Ruppert
      • Potsdam, Germany, 14471
        • Kardiologische Gemeinschaftspraxis am Park Sanssouci
      • Sindelfingen, Germany, 71065
        • Klinikum Sindelfingen-Böblingen gGmbH
      • Stuttgart, Germany, 70199
        • Marienhospital Stuttgart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Indication for implantation (new, boxchange, upgrade) of ICD/ CRT-D
  • Written informed consent
  • Ejection Fraction <= 35%
  • New York Heart Association (NYHA) Class I-III
  • Age >=18 and <=80 years
  • In patient's home environment sufficient infrastructure (analog phone line or sufficient strength of GSM (Global System for Mobile communication) mobile phone network) for running a Merlin@home transmitter is available

Exclusion Criteria:

  • Arterio ventricular (AV) Block III / AV Block II Type Mobitz
  • Severe renal insufficiency
  • Coronary angiology intervention within previous 3 months
  • Myocardial infarction within previous month
  • Life expectancy < 1 year
  • Expected poor data quality / compliance
  • Pregnancy
  • Patient is already participating to another study with active therapy arm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Automatic anonymous ICD/CRTD follow up (quarterly remote follow ups)
Other: Quarterly remote follow ups and remote monitoring
Quarterly remote follow ups and remote monitoring
Active Comparator: Group B1
Personal ICD/CRTD follow up (phone calls + quarterly remote follow ups)
Other: Quarterly remote follow ups + additional phone calls and remote monitoring
Quarterly remote follow ups + additional phone calls and remote monitoring
Active Comparator: Group B2
Personal ICD/CRTD follow up (Quarterly visits)
Other: Quarterly in clinic follow ups and remote monitoring
Quarterly in clinic follow ups and remote monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount of patients with worsened outcome in reference to Packer's "Heart Failure Clinical Composite Response"
Time Frame: 12 months (between 1 and 13 months post implant)
12 months (between 1 and 13 months post implant)

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 12 months (between 1 and 13 months post implant)
12 months (between 1 and 13 months post implant)
Heart failure hospitalizations
Time Frame: 12 months (between 1 and 13 months post implant)
12 months (between 1 and 13 months post implant)
Cardiovascular events
Time Frame: 12 months (between 1 and 13 months post implant)
12 months (between 1 and 13 months post implant)
Number of additional, unscheduled follow ups
Time Frame: 12 months (between 1 and 13 months post implant)
12 months (between 1 and 13 months post implant)
Number of follow ups with relevant findings
Time Frame: 12 months (between 1 and 13 months post implant)
12 months (between 1 and 13 months post implant)
Number of delivered / appropriate ICD therapies
Time Frame: 12 months (between 1 and 13 months post implant)
12 months (between 1 and 13 months post implant)
Quality of life (MLHFQ)
Time Frame: 12 months (between 1 and 13 months post implant)
12 months (between 1 and 13 months post implant)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Study Chair: Christian Weiss, Prof. Dr. med., Städtisches Klinikum Lüneburg gGmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

September 10, 2010

First Submitted That Met QC Criteria

September 10, 2010

First Posted (Estimate)

September 13, 2010

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T94

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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