Decompensation Detection Study

Overview

To gather data and analyze decompensation events.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2008

Arms, Groups and Cohorts

  • 1
    • Algorithm Test Set
  • 2
    • Algorithm Development Set

Clinical Trial Outcome Measures

Primary Measures

  • Data collection and analysis.
    • Time Frame: End of patient follow up.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boston Scientific Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gregory Ewald, M.D., Principal Investigator, Washington University School of Medicine
    • F. Roosevelt Gilliam, M.D., Principal Investigator, Cardiology Associates of Northeast Arkansas

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.