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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Catharina Ziekenhuis Eindhoven
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •chronic heart failure of any cause
- •implanted Medtronic ICD with OptiVol impedance monitoring
Exclusion Criteria
- •inability to receive informed consent
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(end of follow-up)