Venus P-Valve System
Research type
Research Study
Full title
A Real-World Evidence Observational Study of Venus P-Valve System in the Treatment of Patients with Native RVOT Dysfunction.
IRAS ID
327607
Contact name
Shakeel Qureshi
Contact email
Sponsor organisation
Venus Medtech (Hangzhou) Inc.
ISRCTN Number
ISRCTN43511000
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 10 months, 12 days
Research summary
This is post-marketing clinical follow-up study collecting real-world evidence, in a form of new generated data (prospectively) and up to now past data (retrospectively). This will be observational, multicentre study focusing on implantation of medical device calls transcatheter Venus P-ValveTM System in treating patients with moderate or greater pulmonary regurgitation with or without pulmonary stenosis. The patients will be with native right ventricular outflow tract (RVOT) type of heart condition. RVOT dysfunction is frequently associated with congenital heart disease (CHD). There are 9 children per 1000 new-borns, and 1 per 150 adults, 20% with RVOT and pulmonary valve (PV) dysfunction. These patients usually experience right heart failure, resulting in insufficient oxygenated blood circulation.
Clinical data will be collected from at least 10 European sites, 2 of which in the UK. Anticipated participants (N=200) are planned to be followed up for five years for observed outcome measure, which will be analysed and reported to regulatory authorities, like MHRA as required. Post-procedure, a clinical follow-up visit will be scheduled at the discharge in following time intervals: 30 days , 6 months, 1 year and annually thereafter to 5 years.REC name
North of Scotland Research Ethics Committee 1
REC reference
24/NS/0108
Date of REC Opinion
14 Oct 2024
REC opinion
Further Information Favourable Opinion