VCU participates in international sleep apnea study
Tuesday, Feb. 11, 2014
Virginia Commonwealth University announced today that it will enroll patients in a new trial to evaluate the cardiovascular and respiratory benefits of a novel therapeutic option for patients with central sleep apnea (CSA).
CSA is usually associated with cardiac disease and is found in approximately 35 percent of patients with heart failure, but also occurs in patients with atrial fibrillation, coronary artery disease and hypertension.
VCU is one of 25 U.S. centers and nine European centers participating in the remede® System Pivotal Trial. The study will explore the safety and effectiveness of the first implantable stimulation device designed to restore a more normal breathing pattern during sleep for patients with central sleep apnea.
“We are delighted to be one of a select group of centers to offer our patients access to remede System through a clinical trial,” said Keyur B. Shah, M.D., assistant professor in the VCU Pauley Heart Center and heart failure specialist. “The pilot data is very promising that this will prove to be an effective therapy for eliminating apneas and hypopneas during sleep.”
According to Shah, central sleep apnea, which is different from obstructive sleep apnea, is a sleep-related breathing disorder in which patients stop breathing or take shallow breaths while asleep. While patients may be unaware that they have this condition, they may experience excessive daytime drowsiness, poor concentration, decreased libido and impotence. The disease is often present in patients with a history of heart disease, heart failure or atrial fibrillation.
According to the Heart Failure Society of America, heart failure (HF) affects nearly six million people in the United States and more than 23 million worldwide. Heart failure occurs when the heart is unable to pump enough blood to meet the body’s demands, usually due to the heart’s inability to contract or relax properly. About one-third of patients with heart failure have central sleep apnea. Research suggests that people with sleep-disordered breathing and heart disease may be at risk of ventricular arrhythmias and sudden death because of a decrease in their blood oxygen level.
The remede System is an implantable pacemaker-like device that is designed to improve Respiratory Rhythm Management™ and to restore a more regular breathing pattern during sleep. The device delivers electrical pulses through an implantable lead to one of the body’s two phrenic nerves. The diaphragm responds by restoring a more natural, less disrupted, breathing pattern. The therapy is intended to restore quality sleep, improve oxygenation and could lead to improved cardiovascular outcomes for patients with heart failure.
“Demonstrating our commitment to patients, Virginia Commonwealth University is proud to announce its participation in the remede System Pivotal Trial,” said Richard K. Shepard, M.D., associate professor in the VCU Pauley Heart Center and the implanting physician of the device. “We recognize the potential benefits to patients suffering from central sleep apnea by restoring regular breathing and improving respiratory and cardiovascular health. We look forward to contributing to the trial in a meaningful way.”
The remede System Pivotal Trial is conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA), and it has the CE mark and is currently approved for use in the European Union.