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

NCT ID: NCT00488501

Last Updated: 2009-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-01-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* inability to receive informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role lead

Responsible Party

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Stichting Toegepast Wetenschappelijk Cardiologisch Onderzoek

Principal Investigators

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P Houthuizen, MD

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis Eindhoven

A Meijer, MD PhD

Role: STUDY_DIRECTOR

Catharina Ziekenhuis Eindhoven

Locations

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Catharina Ziekenhuis

Eindhoven, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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M06-16106

Identifier Type: -

Identifier Source: org_study_id

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