Decompensation Detection Study

Completed

• Conditions: Heart Failure

• Registration Number: NCT00583089
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

To gather data and analyze decompensation events.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-28
• Study First Posted: 2007-12-31
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 699

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Data collection and analysis.	End of patient follow up.