AGH Cardiovascular Team Explores Implantable Device Designed to Treat Congestive Heart Failure

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Allegheny General Hospital is enrolling patients in a landmark clinical trial to explore the use of a promising investigational technology designed to treat congestive heart failure. The Barostim HOPE4HF clinical trial will evaluate the effectiveness and safety of Barostim neo, a second generation implantable device that electrically activates the baroreceptors, the body’s natural blood pressure sensors that regulate heart function.

Barostim neo

Barostim Therapy initially was studied in more than 500 patients with excellent results. With a new system that’s smaller and more easily placed, we hope to see even further improved patient outcomes.

Allegheny General Hospital (AGH), an affiliate of the Allegheny Health Network, is enrolling patients in a landmark clinical trial to explore the use of a promising investigational technology designed to treat congestive heart failure by stimulating the body’s natural mechanism for blood pressure regulation.

The Barostim HOPE4HF clinical trial will evaluate the effectiveness and safety of Barostim neo, a second generation implantable device that electrically activates the baroreceptors, the body’s natural blood pressure sensors that regulate heart function. The system is designed to signal the brain to relax the arteries to facilitate blood flow, slow the heart allowing more time for it to fill with blood, and prompt the kidneys to reduce fluid in the body, reducing the heart’s workload. This, in turn, is designed to improve heart function and reduce heart failure symptoms.

“Barostim Therapy initially was studied in more than 500 patients with excellent results,” said Srinivas Murali, MD, Director of Allegheny General’s Division of Cardiovascular Medicine and Medical Director of the hospital’s Cardiovascular Institute. “With a new system that’s smaller and more easily placed, we hope to see even further improved patient outcomes.”

Perfecting a device that can help the heart work more efficiently would be an important advance for the 5.1 million adults living with heart failure in the US. Statistics show that 670,000 new cases are diagnosed each year and more than 277,000 people die annually of the disease. In western Pennsylvania and in the rest of the country, heart failure is the leading cause of hospitalization for those over the age of 65.

In heart failure, the heart cannot pump enough blood to support the body. Impaired heart function results in shortness of breath, exercise intolerance and fluid retention. Those with heart failure are six to nine times more likely to experience sudden cardiac death than their healthy counterparts.

Barostim neo is a pacemaker-like device consisting of two parts: a small pulse generator implanted under the collar bone which is connected by a think wire to a small lead implanted unilaterally either on the left or the right carotid artery. An external programmer is used by doctors to non-invasively transmit and regulate energy from the generator to the small lead.

Barostim neo is adjustable to each patient’s unique needs. The device operates automatically and continuously, eliminating the possibility of noncompliance with treatment recommendations.

Barostim neo was developed by CVRx, Inc., a privately held company based in Minneapolis.

The device achieved promising clinical results in European studies. AGH and a handful of other elite US medical centers will be enrolling up to sixty patients in the American study.

To enroll, patients must have a left ventricular ejection fraction less than or equal to 35 percent and be classified as having New York Heart Association Class III Heart Failure.

For more information on the study, contact Sheila Bernardini, RN, Research Coordinator, at 412-359-3281or sbernard(at)wpahs(dot)org or visit the study website at http://www.HeartfailureTrial.com.

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About AGH Cardiovascular Institute: Allegheny General Hospital’s Cardiovascular Institute offers comprehensive, state-of-the-art care for the complete spectrum of cardiovascular disease. The Institute’s nationally recognized medical staff includes specialists in general and interventional cardiology, electrophysiology, leading edge diagnostic cardiology – including cardiovascular MRI, CT and 3-D echocardiography - women’s heart care, heart failure and pulmonary hypertension, heart transplantation and mechanical circulatory support, vascular surgery and wound care, thoracic surgery, heart valve disease and coronary artery bypass surgery.

The hospital’s broad scope of advanced capabilities in the treatment of heart failure offers patients access to cutting edge investigational therapies being explored in clinical trials, such as new medicines and implantable devices designed to more effectively monitor disease progression and treat conditions before they require hospitalization.

About the Allegheny Health Network:
Allegheny Health Network is an integrated healthcare delivery system serving the Western Pennsylvania region. The Network is comprised of eight hospitals, including its flagship academic medical center Allegheny General Hospital, Allegheny Valley Hospital, Canonsburg Hospital, Forbes Hospital, Jefferson Hospital, Saint Vincent Hospital, Westfield Memorial Hospital and West Penn Hospital; the Allegheny-Singer Research Institute; a soon-to open medical mall; and a healthcare group purchasing organization. The Network employs approximately 17,000 people, including more than 2,100 physicians on its medical staff. The Network also serves as a clinical campus for both Temple University School of Medicine and Drexel University College of Medicine.

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Jennifer Davis
Allegheny General Hospital
412-330-4439
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