November 25, 2019
Jacksonville, FL – Memorial Hospital Jacksonville announced that it has initiated a large clinical study (RELIEVE-HF) of a novel medical device designed to help patients with advanced heart failure, irrespective of their ejection fraction (reduced or preserved; also referred to as systolic and diastolic heart failure, respectively). “This is truly the latest in heart failure treatment options and we were pleased to be the first cardiologists in northeast Florida to implant a patient using a minimally invasive procedure,” said Principal Investigator and interventional cardiologist Sumant Lamba, MD.
“This device will offer patients another option to decrease left atrial pressure, which is a major cause of heart failure and admission to hospital,” said interventional cardiologist Vaqar Ali, MD, who implanted the device at Memorial Hospital Jacksonville today
In severe heart failure, even with optimized medical therapy, 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 elevated left atrial pressure can lead to fluid pressure backing up into lungs, causing patients to have difficulty breathing. The fluid pressure buildup in the lungs also leads to >90% of heart failure hospitalizations.
The V-Wave interatrial shunt device is designed to continuously reduce excess left atrial pressure by shunting a small volume of blood from the left atrium to the right atrium. This is expected to reduce the fluid pressure backing up into the lungs – the primary cause of breathing difficulty and hospital admissions in heart failure. 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, such as the V-Wave interatrial shunt, 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 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 world-wide.
Prior clinical experience with the V-Wave shunt demonstrated the safety of the device and implantation procedure. At one year, the V-Wave shunt was associated with statistically significant improvements in symptoms, quality of life, and exercise capacity without objective worsening of cardiac function. Followup is now available in certain patients for 3 years and results support continued efficacy.
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