Clinical Trial: VenusP-Valve™ System Long-term Follow-up 6-10 Years

U.S., April 16 -- ClinicalTrials.gov registry received information related to the study (NCT07531303) titled 'VenusP-Valve™ System Long-term Follow-up 6-10 Years' on April 30, 2025.

Brief Summary: The goal of this study is to assess the long-term safety, efficacy and performance of VenusP-Valve™ implantation. in all subjects who provided informed consent and received VenusP-Valve™ implantation in the VenusP-Valve™ system CE registration study (Protocol ID Number: VMT-001CE; NCT02846753).

Annual clinic visits will be conducted from year 6 through year 10 post-implantation, including transthoracic echocardiography, New York Heart Association (NYHA) functional classification assessment, adverse event evaluation, and r...