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RECRUITING
NCT04195984
NA

Mi-thos® Transcatheter Mitral Valve Replacement Study

Sponsor: Shanghai NewMed Medical Co., Ltd.

View on ClinicalTrials.gov

Summary

To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.

Official title: Evaluation of the Efficacy and Safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in Patients with Severe Mitral Valve Disease At High Surgical Risk.

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

122

Start Date

2021-03-25

Completion Date

2027-01

Last Updated

2025-02-13

Healthy Volunteers

No

Interventions

DEVICE

Mi-thos® valve and transapical delivery system

Transcatheter mitral valve replacement system

Locations (3)

Fuwai hospital

Beijing, Beijing Municipality, China

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Xijing hospital

Xi’an, Shanxi, China