Actively Recruiting
MITRIS China Post Market Clinical Follow-up (PMCF) Study
Led by Edwards Lifesciences · Updated on 2025-12-30
250
Participants Needed
13
Research Sites
699 weeks
Total Duration
On this page
Sponsors
E
Edwards Lifesciences
Lead Sponsor
E
Edwards (Shanghai) Medical Products Co. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Collect clinical outcomes on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement of their native or prosthetic mitral valve with or without concomitant procedures.
CONDITIONS
Official Title
MITRIS China Post Market Clinical Follow-up (PMCF) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older at the time of informed consent
- Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery
- Provide signed written informed consent prior to the study participation
- Willingness to follow protocol requirements
You will not qualify if you...
- Active endocarditis within 3 months prior to the procedure
- Stage 4 renal disease or requiring dialysis (eGFR < 30 is excluded)
- Life expectancy less than 2 years due to non-cardiovascular life-threatening disease
- High predicted risk of mortality prior to procedure with STS PROM > 8 or surgeon estimated risk of mortality > 8
- Participating in a drug or device study that has not reached its primary endpoint (national registries are allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
2
Fuwai Hospital, CAMS & PUMC
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
3
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, China, 361008
Actively Recruiting
4
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
5
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
6
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China, 451460
Actively Recruiting
7
Wuhan Asia Heart Hospital
Wuhan, Hubei, China, 430022
Actively Recruiting
8
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
9
Nanjing First Hospital
Nanjing, Jiangsu, China, 210012
Actively Recruiting
10
The First Affiliated Hospital of XI'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
11
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
12
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Actively Recruiting
13
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China, 315046
Actively Recruiting
Research Team
H
Honglei Sun
CONTACT
W
WeiDavid Zhang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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