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Decompensation Detection Study

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ClinicalTrials.gov Identifier: NCT00583089
Recruitment Status : Completed
First Posted : December 31, 2007
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
To gather data and analyze decompensation events.

Condition or disease
Heart Failure

Study Type : Observational
Actual Enrollment : 699 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Decompensation Detection Study
Study Start Date : March 2006
Primary Completion Date : March 2008
Study Completion Date : March 2008

Group/Cohort
1
Algorithm Test Set
2
Algorithm Development Set



Primary Outcome Measures :
  1. Data collection and analysis. [ Time Frame: End of patient follow up. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Heart failure patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00583089


Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Gregory Ewald, M.D. Washington University School of Medicine
Principal Investigator: F. Roosevelt Gilliam, M.D. Cardiology Associates of Northeast Arkansas

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00583089     History of Changes
Other Study ID Numbers: DECODE
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases