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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00488501
• Other study ID #: M06-16106
• Status: Completed
• Phase: N/A
• First received: June 19, 2007
• Last updated: November 9, 2009
• Start date: July 2007
• Est. completion date: January 2009

Study information

• Verified date: November 2009
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• chronic heart failure of any cause

• implanted Medtronic ICD with OptiVol impedance monitoring

Exclusion Criteria:

• inability to receive informed consent

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Netherlands	Catharina Ziekenhuis	Eindhoven

Sponsors (2)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven	Medtronic

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	influence of left ventricular filling pattern and brain natriuretic level on the positive predictive value of the Optivol alert		end of follow-up	No