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
  Purpose

To gather data and analyze decompensation events.


Condition
Heart Failure.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Decompensation Detection Study

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Data collection and analysis. [ Time Frame: End of patient follow up. ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: March 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Algorithm Test Set
2
Algorithm Development Set

  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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Jeffrey VonArx, Ph.D./Director, Technology Research, Boston Scientific CRM
ClinicalTrials.gov Identifier: NCT00583089     History of Changes
Other Study ID Numbers: DECODE
Study First Received: December 20, 2007
Last Updated: August 1, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014