Assess Measurements of Wireless Cardiac Output Device (Remote-CO-1)

October 14, 2014 updated by: Aventyn, Inc.

Validation of Measurements From CoVa Sensor (VALIDATION-CO-1) Study to Assess Measurements of Wireless Cardiac Output Device

Heart failure is a common cardiovascular problem which is increasing in both prevalence and incidence and associated with substantial morbidity and mortality. The management of heart failure patients is complex and has become a priority world over. Effective methods to keep heart failure patients out of the hospital are essential, both in the interests of the patient's health, as well as to reduce the burden on the health care system

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Heart failure patients should be in a position to provide readings of their weight, blood pressure, fluid intake, thoracic fluid, heart rate, heart rate variability, respiration rate, stroke volume, cardiac output, medications and other important parameters and communicate this data to care providers using wireless technology. This data should be made available to medical personnel regularly and on a periodic basis. In this manner the health care providers can detect and respond to warning signs or alerts before the patient's condition worsens to warrant a visit to the doctor or a hospital admission with features of heart failure decompensation. Programs for chronic heart failure that include remote monitoring have been shown to have a positive effect on clinical outcomes in community dwelling patients with chronic heart failure.

In preparation for a study evaluating the effectiveness of mobile monitoring, the value of Stroke Volume and Cardiac Output need to be validated against FDA approved devices that are available in a hospital or clinic setting. This study covers the validation of the measurements taken with the proposed home monitoring device, Perminova's CoVaTM Sensor (Sensor) against clinic devices such as bio-impedance devices, echocardiogram, Doppler and/or MRI

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Scottsdale Cardiovascular Center

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

Probability Sample

Study Population

This study is targeted towards at-risk heart failure patients. An "at-risk" patient is defined as a patient who has risk factors for Heart Failure as described in the table below

Description

Inclusion Criteria:

  • Subjects of either gender above the age of 18 years
  • The subject is able and willing to provide written informed consent prior to enrollment in the study
  • One or more of the following diagnosis
  • New York Heart Association (NYHA) classification class of I-IV or Stages A-D
  • Symptoms of dyspnea
  • Chronic renal failure on renal replacement therapy

Exclusion Criteria:

  • Patients who may not come for follow up or likely to drop out of the study
  • Any illness which may preclude regular follow up
  • Patient is unable or not willing to wear electrode patches as required
  • Patient has skin sensitivity to adhesive or hydrogel materials used in electrode patches
  • Patient is considered by the PI to be medically unsuitable for study participation

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measuring Cardiac Output for wireless transmission as per discharge guideline
Time Frame: 2 Weeks
2 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aventyn, Inc.

Collaborators

Baxter Healthcare Corporation
Intel Corporation
BMS Hospital Trust

Investigators

  • Principal Investigator: Kris Vijay, MD, MS, FACC, Scottsdale Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

September 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

September 20, 2014

First Submitted That Met QC Criteria

September 26, 2014

First Posted (Estimate)

September 30, 2014

Study Record Updates

Last Update Posted (Estimate)

October 16, 2014

Last Update Submitted That Met QC Criteria

October 14, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AV.CO.v0-01

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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