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
  Purpose

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


Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Catharina Ziekenhuis Eindhoven:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 29
Study Start Date: July 2007
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • inability to receive informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488501

Locations
Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands, 5602 ZA
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Medtronic
Investigators
Principal Investigator: P Houthuizen, MD Catharina Ziekenhuis Eindhoven
Study Director: A Meijer, MD PhD Catharina Ziekenhuis Eindhoven
  More Information

No publications provided

Responsible Party: Mrs. A. van Pol-Spiering, Stichting Toegepast Wetenschappelijk Cardiologisch Onderzoek
ClinicalTrials.gov Identifier: NCT00488501     History of Changes
Other Study ID Numbers: M06-16106
Study First Received: June 19, 2007
Last Updated: November 9, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Catharina Ziekenhuis Eindhoven:
intrathoracic impedance
cardiac resynchronization therapy
heart failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014