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Completed

NCT Number: NCT00488501

Clinical Usefulness and Efficacy of Intrathoracic Impedance Monitoring Using the OptiVol Patient Alert(TM)

In this study we investigate the clinical value and efficacy of OptiVol (TM) impedance measurements by Medtronic (R) ICD's. We aim to determine sensitivity and positive predictive value for detecting heart failure. We also investigate if left ventricular filling pattern measured by echocardiography and/or brain natriuretic peptide (BNP) level can be used to improve the positive predictive value of the Optivol alert

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Catharina Ziekenhuis

Eindhoven, 5602 ZA, Netherlands

About this study

Patients who have a Medtronic (R) ICD equipped with the Optivol (TM) impedance monitoring will be included in your study after informed consent. The OptiVol (TM) feature will be activated and at baseline data is collected (blood sample including BNP, electrocardiography, echocardiography, chest X-ray and ICD check-up). During follow-up patients will be re-assessed in case of an OptiVol alert or in case of heart failure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • chronic heart failure of any cause
  • implanted Medtronic ICD with OptiVol impedance monitoring

Exclusion criteria

  • inability to receive informed consent

Treatment and study plan

Primary outcomes

  1. clinical efficacy and value of ambulatory intrathoracic impedance measurement of the Optivol alert as an indicator of decompensated heart failure reflected by sensitivity and positive predictive value

    Time frame: end of follow-up

Secondary outcomes

  1. influence of left ventricular filling pattern and brain natriuretic level on the positive predictive value of the Optivol alert

    Time frame: end of follow-up

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Collaborators

  • Medtronic

Registry information

Official study title

Clinical Usefulness and Efficacy of Intrathoracic Impedance Monitoring Using the OptiVol Patient Alert(TM) in Medtronic(R) ICD's for Early Detection of Decompensated Heart Failure

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Jun 20, 2007
Registry last updated
Nov 10, 2009

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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