V-Wave said today it launched a new trial of its minimally invasive interartrial shunt designed to treat patients with symptomatic heart failure.
The new Relieve-HF trial aims to enroll 500 patients in a pivotal study of the device, which is designed for patients with NHYA Class III and ambulatory Class IV symptomatic heart failure, the Israel-based company said.
“The interatrial shunt provides a novel therapeutic approach for patients with chronic HF. The shunt is implanted through a catheter inserted in a vein in the leg. Prior clinical experience demonstrated device and implantation procedure safety, and statistically significant improvements in symptoms, quality of life measurements, and exercise capacity were observed compared to a matched population receiving optimal care. We are fortunate to have our study designed by the world’s leading HF clinical trialists: Drs. William Abraham from the Ohio State University, Gregg Stone, from Columbia University, JoAnn Lindenfeldof Vanderbilt University, Stefan D. Anker from Charité Berlin, Germany, and Josep Rodés-Cabau, MD, Laval University, Quebec. These extraordinary physicians have planned and executed some of the most influential and successful HF and structural heart disease device trials,” CEO Dr. Neal Eigler said in a press release.
V-Wave said that it has enrolled two patients in the study so far, and that both were successfully implanted with the stent and discharged home from the Ohio State University Wexner Medical Center, where Dr. Garrie Haas serves as principal investigator.
The company said that 50 hospitals in North America are expected to participate in the study, and that it hopes to add an additional 25 centers in the European Union and Israel.
Primary effectiveness outcome measures in the study include a hierarchical composite of mortality, heart transplant or ventricular assist device implantation, HF hospitalizations and change in six-minute walk test distance.
“Elevations in left atrial pressure cause fluid to back-up in the lungs resulting in difficulty breathing; uncontrolled elevations in LAP are the most common cause (>90%) of acute hospitalizations for HF. The shunt continuously regulates LAP without patient or physician intervention by diverting a small portion of blood flow from the left to the right atrium, preventing uncontrolled LAP elevations. The Relieve HF trial will study the safety and effectiveness of the V-Wave shunt in patients with heart failure who remain highly symptomatic despite best medical treatments,” Dr. Gregg Stone of Columbia University and the New York-Presbyterian Hospital / Columbia University Medical Center said in a prepared statement.
In April, V-Wave said that it raised $70 million in a closed Series C round of financing, with funds slated to support the launch of a pivotal trial of its investigational interatrial shunt device designed for patients with advanced heart failure.