VentriPoint Diagnostics announced the initiation of a clinical trial to validate its VMS 3D imaging technology in patients with the most common form of congenital heart disease, Tetralogy of Fallot or Blue-baby Syndrome. Data from the trial will underpin a submission to the FDA, which is slated for the end of this year.
The trial is being led by John Kovalchin, director of Echocardiography at The Heart Center at Nationwide Children’s Hospital in Columbus Ohio, USA. It is expected to enrol 83 patients at five centres in the United States. Eight patients have already been enrolled.
“We are pleased to be collaborating with VentriPoint on this project” said Kovalchin.
“With this trial, the company is positioning itself to become the standard of care for measuring right ventricular volumes in a manner that is cost-effective, accessible and accurate,” said George Adams, VentriPoint’s CEO.
In addition to the multicenter trial, Kovalchin and colleagues will be evaluating the risks and benefits of the VMS in difficult-to-image adult and paediatric patients. They will explore the usefulness of the VMS in the ‘hybrid cath lab’for the assessment of right-ventricular function before and after percutaneous-valve replacement.
The VMS is an investigational use device only in the United States and is approved for clinical use in Canada and Europe.