CClinicalTrials.gg
CompletedNCT00583089Updated Feb 6, 2017

Decompensation Detection Study

An observational study in Heart Failure, sponsored by Boston Scientific Corporation. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-06.

Sponsored by Boston Scientific Corporation · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
699
Ages
18 Years and older
Sex
All
01

Study summary

To gather data and analyze decompensation events.

02

Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 699 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Heart failure patients

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
699 participants (actual)

Groups and cohorts

  • 1

    Algorithm Test Set

  • 2

    Algorithm Development Set

06

What researchers measure

Primary outcomes

  1. Data collection and analysis.

    Time frame: End of patient follow up.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00583089
Lead sponsor
Boston Scientific Corporation
Responsible party
Sponsor
First posted
Dec 31, 2007
Start date
Mar 2006
Primary completion
Mar 2008
Completion
Mar 2008
Last update
Feb 6, 2017

Study contacts

Gregory Ewald, M.D.
principal investigator · Washington University School of Medicine
F. Roosevelt Gilliam, M.D.
principal investigator · Cardiology Associates of Northeast Arkansas

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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