Decompensation Detection Study - Full Text View

Decompensation Detection Study

This study is ongoing, but not recruiting participants.

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00583089

Purpose

To gather data and analyze decompensation events.

Condition

Heart Failure.

MedlinePlus related topics:

Heart Failure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	Decompensation Detection Study

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

Data collection and analysis. [ Time Frame: End of patient follow up. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	700
Study Start Date:	March 2006
Estimated Study Completion Date:	March 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Algorithm Test Set

Algorithm Development Set

Eligibility

Study Population

Heart failure patients

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583089

Sponsors and Collaborators

Boston Scientific Corporation

Investigators


Principal Investigator:	Gregory Ewald, M.D.	Washington University Medical Center

Principal Investigator:	F. Roosevelt Gilliam, M.D.	Cardiology Associates of Northeast Arkansas

More Information

Responsible Party:	Boston Scientific CRM ( Jeffrey VonArx, Ph.D./Director, Technology Research )
Study ID Numbers:	DECODE
First Received:	December 20, 2007
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00583089
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Heart Failure

Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 31, 2008