Clinical Usefulness and Efficacy of Intrathoracic Impedance Monitoring Using the OptiVol Patient Alert(TM)
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| First Received Date ICMJE | June 19, 2007 | ||||||||
| Last Updated Date | November 9, 2009 | ||||||||
| Start Date ICMJE | July 2007 | ||||||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00488501 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Clinical Usefulness and Efficacy of Intrathoracic Impedance Monitoring Using the OptiVol Patient Alert(TM) | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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 |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | patients who have been implanted a biventricular pacemaker ICD equipped with impedance monitoring and who are known with chronic heart failure of any cause |
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| Condition ICMJE | Heart Failure | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 29 | ||||||||
| Completion Date | January 2009 | ||||||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00488501 | ||||||||
| Other Study ID Numbers ICMJE | M06-16106 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Mrs. A. van Pol-Spiering, Stichting Toegepast Wetenschappelijk Cardiologisch Onderzoek | ||||||||
| Study Sponsor ICMJE | Catharina Ziekenhuis Eindhoven | ||||||||
| Collaborators ICMJE | Medtronic | ||||||||
| Investigators ICMJE |
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| Information Provided By | Catharina Ziekenhuis Eindhoven | ||||||||
| Verification Date | November 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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