NCT00919828

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2009

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 4, 2010

Status Verified

February 1, 2010

Enrollment Period

9 months

First QC Date

June 10, 2009

Last Update Submit

February 2, 2010

Conditions

Heart Failure

Interventions

Avivo SystemDEVICE

Non invasive external monitoring device

Also known as: external monitoring systems

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart failure patients

You may qualify if:

  • 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

You may not qualify if:

  • Is participating in another clinical study that may confound the results of this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 10, 2009

First Posted

June 12, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 4, 2010

Record last verified: 2010-02