NCT00583089

Brief Summary

To gather data and analyze decompensation events.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
699

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 31, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

February 6, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

December 20, 2007

Last Update Submit

February 2, 2017

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Data collection and analysis.

    End of patient follow up.

Study Arms (2)

1

Algorithm Test Set

2

Algorithm Development Set

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart failure patients

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Gregory Ewald, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

  • F. Roosevelt Gilliam, M.D.

    Cardiology Associates of Northeast Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 31, 2007

Study Start

March 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

February 6, 2017

Record last verified: 2017-02