Decompensation Detection Study

NCT ID: NCT00583089

Last Updated: 2017-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

699 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To gather data and analyze decompensation events.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Algorithm Test Set

No interventions assigned to this group

2

Algorithm Development Set

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gregory Ewald, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

F. Roosevelt Gilliam, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cardiology Associates of Northeast Arkansas

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DECODE

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

BIOSTREAM.HF HeartInsight
NCT05761249 COMPLETED