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NCT05404880

INSPIRIS China PMCF Study

Sponsor: Edwards Lifesciences

View on ClinicalTrials.gov

Summary

The objective of this post-market trial is to evaluate long term safety and performance of the Edwards Lifesciences INSPIRIS RESILIA aortic valve in Chinese patients in a real-world clinical setting.

Official title: Post-Market Clinical Follow-up Study of Edwards Lifesciences INSPIRIS RESILIA Aortic Valve in Chinese Population

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

255

Start Date

2022-07-13

Completion Date

2029-12

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

DEVICE

EDWARDS INSPIRIS RESILIA Aortic Valve

Surgical replacement of the aortic valve with the INSPIRIS RESILIA Aortic Valve.

Locations (13)

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Hefei, Anhui, China

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Fuwai Hospital, CAMS & PUMC

Beijing, Beijing Municipality, China

Xiamen Cardiovascular Hospital Xiamen University

Xiamen, Fujian, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen

Shenzhen, Guangdong, China

Henan Provincial Chest Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

Nanjing First Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Fuwai Yunnan Cardiovascular Hospital

Kunming, Yunnan, China