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OpenTrials
Completed

NCT Number: NCT01200381

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald, Bad Friedrichshall, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quarterly remote follow ups and remote monitoring

Other

Quarterly remote follow ups and remote monitoring

Quarterly remote follow ups + additional phone calls and remote monitoring

Other

Quarterly remote follow ups + additional phone calls and remote monitoring

Quarterly in clinic follow ups and remote monitoring

Other

Quarterly in clinic follow ups and remote monitoring

Primary outcomes

  1. 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)

Secondary outcomes

  1. Mortality

    Time frame: 12 months (between 1 and 13 months post implant)

  2. Heart failure hospitalizations

    Time frame: 12 months (between 1 and 13 months post implant)

  3. Cardiovascular events

    Time frame: 12 months (between 1 and 13 months post implant)

  4. Number of additional, unscheduled follow ups

    Time frame: 12 months (between 1 and 13 months post implant)

  5. Number of follow ups with relevant findings

    Time frame: 12 months (between 1 and 13 months post implant)

  6. Number of delivered / appropriate ICD therapies

    Time frame: 12 months (between 1 and 13 months post implant)

  7. Quality of life (MLHFQ)

    Time frame: 12 months (between 1 and 13 months post implant)

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Acronym: InContact

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 13, 2010
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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