NEW ORLEANS (WAFB) - Ochsner is currently enrolling patients 18 years of age or older with Class II, III, or IV heart failure to participate in what hospital officials say may be one of the largest heart failure medical device trials in the U.S.
CLASSES OF HEART FAILURE DEFINED BY THE AMERICAN HEART ASSOCIATION:
- Class I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.
- Class II – Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation or shortness of breath.
- Class III – Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation or shortness of breath.
- Class IV – Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
The study, called the GUIDE-HF clinical trial, will evaluate improved survival and quality of life in patients with Abbott’s CardioMEMS™ HF System. Specifically, researchers hope to determine if the device can reduce heart failure hospitalization and improve survival and quality of life for people living with Class II, Class III, or Class IV heart failure once it’s implanted.
The device works by transmitting information about a patient’s pressure readings and heart failure status to a clinician using internal sensors. The collected data provides clinicians with the ability to detect worsening heart failure sooner and adjust treatment to reduce the likelihood that the patient will need to be hospitalized.
Data is transmitted once daily via an at-home patient electronic system, which comprises of an electronics unit and paddle-shaped antenna encased inside a pillow. The transmission takes approximately 2 to 3 minutes and reads the pressure measurement from the implanted sensor wirelessly. There is no pain or sensation for the patient who lays down on top of the pillow during the daily reading.
The American Heart Association (AHA) reports nearly 6 million Americans have heart failure and 900,000 new patients are diagnosed each year. . Heart failure is the leading cause of hospitalization in America for adults over the age of 65 and Louisiana has the 5th highest death rate from cardiovascular disease in the country, according to Ochsner.
There’s no question about it – the ability to monitor patients remotely and identify changes in pressure well before other symptoms begin to manifest is a gamechanger for treating patients suffering from heart failure,” said Selim Krim, MD, Cardiomyopathy and Heart Transplantation physician at the John Ochsner Heart and Vascular Institute. Dr. Krim also serves as the principal investigator for this study.
To learn more about this study contact Oschner by calling 504-842-0218.
Ochsner was the seventh site to open nationwide in this clinical trial. By 2023, the trial will include approximately 3,600 subjects at approximately 140 North American sites.