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Monitor Patients With Acute Heart Failure (ACUTE)

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ClinicalTrials.gov Identifier: NCT00919828
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : February 4, 2010
Sponsor:
Information provided by:
Corventis, Inc.

Brief Summary:
This is a prospective, multi-center, non-randomized study to evaluate performance of an external monitor for heart failure patients

Condition or disease Intervention/treatment
Heart Failure Device: Avivo System

Detailed Description:
External monitoring of heart failure patients with the AVIVO System.

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Adherent Monitoring of Congestive Heart Failure During Therapy for Excess Fluid Study
Study Start Date : March 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources


Intervention Details:
    Device: Avivo System
    Non invasive external monitoring device
    Other Name: external monitoring systems



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Heart failure patients
Criteria

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

Responsible Party: Madhuri Bhat, VP Regulatory and Clinical affairs, Corventis
ClinicalTrials.gov Identifier: NCT00919828     History of Changes
Other Study ID Numbers: COR-2009-003
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases