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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT00488501
First received: June 19, 2007
Last updated: November 9, 2009
Last verified: November 2009

June 19, 2007
November 9, 2009
July 2007
December 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00488501 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

patients who have been implanted a biventricular pacemaker ICD equipped with impedance monitoring and who are known with chronic heart failure of any cause

Heart Failure
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
January 2009
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • inability to receive informed consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00488501
M06-16106
No
Mrs. A. van Pol-Spiering, Stichting Toegepast Wetenschappelijk Cardiologisch Onderzoek
Catharina Ziekenhuis Eindhoven
Medtronic
Principal Investigator: P Houthuizen, MD Catharina Ziekenhuis Eindhoven
Study Director: A Meijer, MD PhD Catharina Ziekenhuis Eindhoven
Catharina Ziekenhuis Eindhoven
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP