Israeli medical devices developer V-Wave has started enrolling patients in the controlled RELIEVE-HF clinical trial of its minimally invasive interatrial shunt device to treat symptomatic heart failure (HF).
V-Wave Shunt is a miniature, biocompatible implant designed to regulate and prevent episodes of elevated left atrial pressure, providing symptom relief.
The pivotal, double-blinded, multi-centre trial will assess the safety and effectiveness of the interatrial shunt in severe HF patients having preserved or reduced ejection fraction.
RELIEVE-HF will recruit 500 participants at approximately 50 hospitals in North America and 25 sites across the EU and Israel.
V-Wave CEO Neal Eigler 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.”
The first two subjects in the randomised RELIEVE-HF trial were successfully implanted at the Ohio State University Wexner Medical Center, US.
During the trial, investigators will measure the primary effectiveness outcome as the proportion of implanted patients experiencing major device-related adverse events.
In addition, the study will evaluate a hierarchical composite of mortality, heart transplant or ventricular assist device implantation, HF hospitalisations and change in six-minute walk test distance.
The trial’s secondary outcomes measures include change in 6MWT and Kansas City Cardiomyopathy Questionnaire (KCCQ). Starting last month, RELIEVE-HF is expected to be completed in May 2025.