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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00488501

Enrollment

Registered

2007-06-20

Start date

2007-07-31

Completion date

2009-01-31

Last updated

2009-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

intrathoracic impedance, cardiac resynchronization therapy, heart failure

Brief summary

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

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* inability to receive informed consent

Design outcomes

Primary

Measure	Time frame
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	end of follow-up

Secondary

Measure	Time frame
influence of left ventricular filling pattern and brain natriuretic level on the positive predictive value of the Optivol alert	end of follow-up

Countries

Netherlands

Outcome results