NCT05898230

Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Corcym S.r.l · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the medium- to long-term safety of the Carbomedics OptiForm Mitral Heart Valve after the implantation for mitral valve disease in the Chinese population. The study is designed as a post-market, retrospective, single arm and multicentric data collection

Detailed description

This study is conducted to evaluate the medium and long-term safety of the Carbomedics OptiForm Mitral Heart Valve after the implantation for mitral valve disease. The data will be used for regulatory purposes, to support the re-certification of the valve in the Chinese market. Valve-related SAEs such as prosthetic valve dysfunction, death, valve-related bleeding events, valve thrombosis and thromboembolic events, endocarditis and reintervention will be studied to describe the safety profile of the valve. Data of approximately 400 subjects will be collected in two clinical sites in China.

Conditions

• Mitral Valve Disease

Interventions

Type	Name	Description
DEVICE	Mitral Valve Replacement	Mitral Valve Replacement with Carbomedics OptiForm Mitral Heart Valve

Timeline

• Start date: 2023-11-23
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-06-12
• Last updated: 2024-03-07

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated device study