Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488501
Status:
COMPLETED
Last Update Posted:
2009-11-10
First Post:
2007-06-19
Brief Title:
Clinical Usefulness and Efficacy of Intrathoracic Impedance Monitoring Using the OptiVol Patient AlertTM
Sponsor:
Catharina Ziekenhuis Eindhoven
Organization:
Catharina Ziekenhuis Eindhoven
Study Overview
Official Title:
Clinical Usefulness and Efficacy of Intrathoracic Impedance Monitoring Using the OptiVol Patient AlertTM in MedtronicR ICDs for Early Detection of Decompensated Heart Failure
Status:
COMPLETED
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study we investigate the clinical value and efficacy of OptiVol TM impedance measurements by Medtronic R ICDs We aim to determine sensitivity and positive predictive value for detecting heart failure We also investigate if left ventricular filling pattern measured by echocardiography andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None