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Monitor Patients With Acute Heart Failure (ACUTE)

This study has been completed.
Sponsor:
Information provided by:
Corventis, Inc.
ClinicalTrials.gov Identifier:
NCT00919828
First received: June 10, 2009
Last updated: February 2, 2010
Last verified: February 2010
History of Changes
  Purpose

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


Condition Intervention
Heart Failure
 Device: Avivo System

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Adherent Monitoring of Congestive Heart Failure During Therapy for Excess Fluid Study

Resource links provided by NLM:

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

Further study details as provided by Corventis, Inc.:

Estimated Enrollment: 60
Study Start Date: March 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Avivo System
    Non invasive external monitoring device
    Other Name: external monitoring systems
Detailed Description:

External monitoring of heart failure patients with the AVIVO System.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Madhuri Bhat, VP Regulatory and Clinical affairs, Corventis
ClinicalTrials.gov Identifier: NCT00919828     History of Changes
Other Study ID Numbers: COR-2009-003
Study First Received: June 10, 2009
Last Updated: February 2, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013