Link-HF: Multisensor Non-invasive Telemonitoring System for Prediction of Heart Failure Exacerbation

Completed

Conditions studied: Cardiac Failure

In brief

This is a multi-center, non-randomized, non-interventional study to evaluate the accuracy of a remote monitoring and analytical platform for prediction of heart failure exacerbation. The platform acquires continuous multivariate vital signs from HF patients using a new ambulatory wearable (attached by an adhesive) multi-sensor device and analyzes the data using a novel machine learning algorithm.

Key facts

Study ID

NCT03037710

Run by

Josef Stehlik

People needed

100

Starts

2015-06-01

Expected to finish

2017-01-26

Last updated by the study team

2020-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must be 18 years old or older
• NYHA( New York Heart Association Functional Classification) Class II-IV, documented in site's medical record system.
• Subject able and willing to sign Informed Consent Document.
• Subject willing and able to perform all study related procedures.

You may not qualify if…

• Expected LVAD (Left Ventricular Assist Device) implantation or heart transplantation in the next 30 days.
• Skin damage or significant arthritis, preventing wearing of device.
• Uncontrolled seizures or other neurological disorders leading to excessive abnormal movements or tremors in the upper body.
• Pregnant women or those who are currently nursing.
• Visual/cognitive impairment that as judged by the investigator does not allow the subject to independently follow rules and procedures of the protocol.

Where it is running

• Palo Alto VA Health Care System — Palo Alto, California, United States
• Malcom Randall VA Medical Center — Gainesville, Florida, United States
• Michael E. DeBakey VA Medical Center — Houston, Texas, United States
• George E Wahlen Medical Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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