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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014