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Decompensation Detection Study

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00583089
First received: December 20, 2007
Last updated: August 1, 2011
Last verified: August 2011

December 20, 2007
August 1, 2011
March 2006
March 2008   (final data collection date for primary outcome measure)
Data collection and analysis. [ Time Frame: End of patient follow up. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00583089 on ClinicalTrials.gov Archive Site
Not Provided
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Decompensation Detection Study
Decompensation Detection Study

To gather data and analyze decompensation events.

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

Heart failure patients

Heart Failure.
Not Provided
  • 1
    Algorithm Test Set
  • 2
    Algorithm Development Set
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
700
March 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients implanted with an approved Guidant CRT-D HF device programmed to CRT therapy in VDD or DDD mode.
  • Patients prescribed to the LATITUDE(R) system configured for at least weekly device interrogations and symptoms reporting.
  • Patients willing to use the LATITUDE(R) enabled weight scale.

Exclusion Criteria:

  • Patients that require adaptive rate pacing (rate-responsive modes).
  • Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days.
  • Both
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00583089
DECODE
No
Jeffrey VonArx, Ph.D./Director, Technology Research, Boston Scientific CRM
Boston Scientific Corporation
Not Provided
Principal Investigator: Gregory Ewald, M.D. Washington University School of Medicine
Principal Investigator: F. Roosevelt Gilliam, M.D. Cardiology Associates of Northeast Arkansas
Boston Scientific Corporation
August 2011

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