NCT02252757

Assess Measurements of Wireless Cardiac Output Device

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Aventyn, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

Conditions

• Congestive Heart Failure

Interventions

Type	Name	Description
DEVICE	CoVa

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2014-09-30
• Last updated: 2014-10-16

Locations

1 site across 1 country: United States