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
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: 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 August 28, 2014