- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00919828
Monitor Patients With Acute Heart Failure (ACUTE)
February 2, 2010 updated by: Corventis, Inc.
Adherent Monitoring of Congestive Heart Failure During Therapy for Excess Fluid Study
This is a prospective, multi-center, non-randomized study to evaluate performance of an external monitor for heart failure patients
Study Overview
Detailed Description
External monitoring of heart failure patients with the AVIVO System.
Study Type
Observational
Enrollment (Anticipated)
60
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Heart failure patients
Description
Inclusion Criteria:
- Is female or male, 18 years of age or older
- Has an ejection fraction of 40% reported within 12 months of enrollment
- Having acute decompensated heart failure and receiving treatment for fluid overload
Exclusion Criteria:
- Is participating in another clinical study that may confound the results of this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
June 10, 2009
First Submitted That Met QC Criteria
June 11, 2009
First Posted (Estimate)
June 12, 2009
Study Record Updates
Last Update Posted (Estimate)
February 4, 2010
Last Update Submitted That Met QC Criteria
February 2, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COR-2009-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Tufts Medical CenterMetro West Medical CenterCompletedCongestive Heart Failure | Diastolic Heart Failure | Systolic Heart FailureUnited States
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