Assess Measurements of Wireless Cardiac Output Device

Congestive Heart Failure Clinical Trial

— Remote-CO-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02252757
• Other study ID #: AV.CO.v0-01
• Status: Completed
• Phase: N/A
• First received: September 20, 2014
• Last updated: October 14, 2014
• Start date: September 2014
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Aventyn, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• CoVa

Locations

Country	Name	City	State
United States	Scottsdale Cardiovascular Center	Scottsdale	Arizona

Sponsors (4)

Lead Sponsor	Collaborator
Aventyn, Inc.	BMS Hospital Trust, Intel Corporation, toSense, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Clark RA, Inglis SC, McAlister FA, Cleland JG, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ. 2007 May 5;334(7600):942. Epub 2007 Apr 10. Review. — View Citation

Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF — View Citation

Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, Cleland JG. Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007228. doi: 10.1002/14651858.CD007228.pub2. Review. Update in: Cochrane Database Syst Rev. 2015;10:CD007228. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring Cardiac Output for wireless transmission as per discharge guideline		2 Weeks	No

External Links

•   Evaluate Heart Failure Patients With Specially Designed Patient Adherence and Monitoring Software on Standard Mobile Devices (REMOTE-HF-1)