Israeli medical company V-Wave Ltd stated on Wednesday that it has admitted the first patients under its global, pivotal study of its proprietary, minimally invasive implanted interatrial shunt device for treating NHYA Class III and ambulatory Class IV symptomatic heart failure (HF), the leading cause of hospitalisations in many countries.

The company added the randomised, controlled, double-blinded multi-centre clinical trial, called the RELIEVE-HF study, will evaluate the safety and effectiveness of its novel device therapy in 500 severe HF patients with either preserved or reduced ejection fraction.

In conjunction, the company's RELIEVE-HF study is funded by its USD70m early 2018 C-Round financing. Dr Garrie Haas, the director of the Heart Failure and Transplant Programme is the principal investigator and Drs Scott Lilly (interventional cardiologist) and Rami Kahwash (heart failure cardiologist) are responsible for implantation and patient management, respectively.

According to the company, the first two patients in the RELIEVE-HF study were successfully implanted and discharged home from The Ohio State University Wexner Medical Center. The primary effectiveness outcome measure includes a hierarchical composite of mortality, heart transplant or ventricular assist device implantation, HF hospitalisations and change in six-minute walk test distance.

Approximately 50 major North American hospitals are expected to participate in the company's pivotal study with up to another 25 centres in the EU and Israel.