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

Catharina Ziekenhuis Eindhoven29 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Heart Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * chronic heart failure of any cause * implanted Medtronic ICD with OptiVol impedance monitoring Exclusion Criteria: * inability to receive informed consent

Locations (1)

Catharina Ziekenhuis

Eindhoven, Netherlands

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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