Decompensation Detection Study | NCT00583089

Studies
Decompensation Detection Study

NCT00583089

Sponsor

Boston Scientific Corporation

Status

Completed

Last Update Posted

Feb 6, 2017Estimated

Enrollment

699Actual

Phase

Not provided

Conditions

Heart Failure

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Mar 2008Actual

Completion Date

Mar 2008Actual

First Submitted Date

Dec 20, 2007

First Submission Date that Met QC Criteria

Dec 28, 2007

First Posted Date

Dec 31, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2017

Last Update Posted Date

Feb 6, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

699Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Algorithm Test Set
2		Algorithm Development Set

Interventions

Not provided

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Heart failure patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gregory Ewald, M.D.	Washington University School of Medicine	Principal Investigator
F. Roosevelt Gilliam, M.D.	Cardiology Associates of Northeast Arkansas	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided