VDyne VISTA
Research type
Research Study
Full title
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation
IRAS ID
329175
Contact name
Laura Moffett
Contact email
Sponsor organisation
VDyne Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 5 months, 3 days
Research summary
The study is designed for patients with heart condition called tricuspid regurgitation (TR). This is caused by a defect in the closure of the tricuspid heart valve that causes a large amount of blood to flow back into the right atrium of the heart. Patients may feel weak or tired due to this dysfunction. Treatments typically used to repair or replace a defective tricuspid valve involve open-heart surgery.
VDyne Inc. has developed an artificial heart valve that can be installed without open-heart surgery, passing through a vein in the leg. It includes in its manufacture components from the pig. This artificial heart valve and the tools used to place it in the heart are called the Vdyne Transcatheter Tricuspid Valve Replacement System, or the VDyne System. The VDyne system is an investigational medical device, which means that it is still being studied in research projects like this and is not commercially available.
The objectives of this study are to evaluate the safety and efficacy of the VDyne System in the treatment of moderate to severe tricuspid insufficiency and to collect long-term (5-year) data on the VDyne System and its long-term performance. This trial will include about 40 participants at 20 sites worldwide. Patients will be followed-up for a period of 5 years after having the study device implanted.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
24/EE/0110
Date of REC Opinion
26 Jun 2024
REC opinion
Further Information Favourable Opinion