The trial was conducted by Bruce Wilkoff, the director of Cardiac Pacing and Tachyarrhythmia Devices at Cleveland Clinic and Niraj Varma, professor of medicine at Cleveland Clinic Lerner College of Medicine and consultant electrophysiologist at Cleveland Clinic London.

 

The INTEGRA-D clinical study was sponsored by Impulse Dynamics, the manufacturer of the device, which will enroll 300 patients from 75 centers across the US who will be followed for two years.

 

It will evaluate the safety and effectiveness of a device that combines two proven cardiac therapies into one. 

Cardiac contractility modulation works to improve the contraction of the heart, while an implantable cardioverter defibrillator (ICD) treats life-threatening arrhythmias that cause sudden cardiac death.

 

For the clinical trial, Wilkoff was the principal investigator, while Varma assumed the role of the national primary investigator.

 

"This could be an important advancement for heart failure patients, requiring just one procedure to deliver two important therapies and prevent sudden cardiac death," said an excited Wilkoff. 

 

"The hope is that this rechargeable technology – with a potential battery life of up to 20 years – will significantly reduce the need for replacement procedures," he added.

 

According to the World Heart Federation, factors such as aging populations, an increase in cardiovascular risk factors and improved survival of cardiovascular conditions, the prevalence of heart failure is increasing globally to an estimated number of 26 million, with additional millions of undiagnosed cases.

 

Patients with heart failure experience debilitating symptoms, including breathlessness, fatigue, confusion and swelling in the legs that can greatly diminish quality of life. 

 

Most heart failure patients are prescribed medications that work to slow the disease’s progression and manage symptoms, but effectiveness can wane over time. While standard, existing implantable cardiovascular defibrillators are lifesaving, the technology alone does not improve the debilitating symptoms of heart failure.

 

"We are looking forward to studying this new technology to determine its potential to advance treatments for patients living with heart failure," stated Varma.

 

Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the US.

 

Located in Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation.-TradeArabia News Service