VentriPoint Diagnostics has announced the start 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.
This trial is being led by Dr. John Kovalchin, Director of Echocardiography at The Heart Center at Nationwide Children's Hospital in Columbus Ohio.
Dr. Kovalchin has already enrolled eight patients into the trial, which is planned to enroll a total of 83 patients at five centers in the United States. Other centers will be announced as they begin enrollment.
"We are pleased to be collaborating with VentriPoint on this project" said Dr. Kovalchin.
Data from the trial will underpin a submission to the FDA, which is slated for the end of this year.
According to Dr. George Adams, CEO, "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".
In addition to the multicenter trial, Dr. Kovalchin and his colleagues will be evaluating the risks and benefits of the VMS™ in difficult-to-image adult and pediatric patients. They will explore the usefulness of the VMS in the 'hybrid cath lab'(i) for the assessment of right-ventricular function before and after percutaneous-valve replacement.
(i)(A hybrid catheterization lab combines diagnostic functions, e.g. 'cath' lab, with the surgical functions of an operating room.)
The VMS™ is an investigational use device only in the United States and approved for clinical use in Canada and Europe.