Decompensation Detection Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00583089

Enrollment

699

Registered

2007-12-31

Start date

2006-03-31

Completion date

2008-03-31

Last updated

2017-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

To gather data and analyze decompensation events.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Data collection and analysis.	End of patient follow up.

Outcome results