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FCCI Physicians First in the Area to Implant Novel Heart Failure Device

Drs. Vaqar Ali and Sumant Lamba are the first in the area to implant a new device that may potentially improve symptoms for heart failure patients. “This is truly the latest in heart failure treatment options,” said Principal Investigator and interventional cardiologist, Dr. Lamba. The device is called the V-Wave interatrial shunt device and is being implanted at Memorial Hospital Jacksonville as part of a large clinical study called RELIEVE-HF.

In severe heart failure, the heart is not able to effectively pump blood out to the body and fluid pressure builds up in the heart, including in the left atrium. This pressure can lead to fluid pressure backing up into lungs, causing patients to have difficulty breathing and leading to over 90% of heart failure hospitalizations.

“This device may offer patients an option to potentially decrease left atrial pressure, which is a major cause of heart failure and admission to hospital,” said interventional cardiologist, Dr. Ali, who implanted the device at Memorial Hospital Jacksonville.

The investigational device is a tiny hourglass shaped shunt that is placed between the two upper chambers of the heart using a minimally invasive procedure through a catheter placed in the femoral vein in the leg. The procedure is performed in a hospital under sedation or anesthesia and typically takes around one hour.

Heart failure is a serious global disease affecting more than 26 million people worldwide and more than 6 million people in the US alone, with more than 800,000 new cases each year. Even with medication, patients with severe heart failure have a very poor prognosis and a large percentage of patients remain highly symptomatic. New therapies are needed to improve quality of life, exercise capacity, and life-expectancy, and to reduce the high risk of hospitalization.

The RELIEVE-HF study is a global pivotal study designed to evaluate safety, as well as the effectiveness of the V-Wave interatrial shunt in reducing heart failure symptoms and hospitalizations. The clinical trial will include patients with advanced heart failure (New York Heart Association Class III or ambulatory Class IV) who experience symptoms with minimal or no exertion and have either reduced or preserved ejection fractions (systolic or diastolic heart failure). The trial will enroll about 500 patients worldwide.

https://clinicaltrials.gov/ct2/show/NCT03499236

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