Actively Recruiting
Safety and Effectiveness of TaurusTrio™ Heart Valve System in Patients With Severe Aortic Regurgitation (AR)
Led by Peijia Medical Technology (Suzhou) Co., Ltd. · Updated on 2024-03-18
116
Participants Needed
19
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and effectiveness of the TaurusTrio™ Heart Valve System in a patient population with symptomatic severe AR requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR).
CONDITIONS
Official Title
Safety and Effectiveness of TaurusTrio™ Heart Valve System in Patients With Severe Aortic Regurgitation (AR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who voluntarily participate and sign the informed consent and can comply with the entire trial process
- Age 18 years or older
- Adults with severe aortic regurgitation (Grade 3 or higher) confirmed by echocardiography using specific measurements
- Symptoms caused by aortic regurgitation such as shortness of breath, chest pain, or NYHA Class II or higher
- Patients unsuitable for conventional surgery but needing transcatheter aortic valve replacement, as evaluated by a cardiac team including an interventional cardiologist and cardiovascular surgeon
- Suitable anatomy for insertion and delivery of the JenaValve Trilogy14 Heart Valve System as evaluated by core laboratory
You will not qualify if you...
- Congenital uni- or bicuspid aortic valve morphology
- Previous prosthetic aortic valve implant (bioprosthesis or mechanical)
- Moderate or greater mitral or tricuspid regurgitation
- Clinically significant coronary artery disease requiring revascularization within 30 days before or planned within 12 months after the procedure
- Left ventricular thrombus detected by echocardiography
- Endocarditis within 180 days before the procedure
- Hypertrophic cardiomyopathy with or without obstruction
- Severe pulmonary hypertension (systolic pulmonary artery pressure >80 mmHg)
- Severe right ventricular dysfunction by clinical and echocardiographic assessment
- Severely reduced left ventricular ejection fraction below 25%
- Aortic annular perimeter diameter less than 21.0 mm or greater than 28.6 mm or perimeter less than 66.0 mm or greater than 90 mm
- Aortic annulus angulation greater than 70 degrees
- Ascending aorta straight length less than 55 mm
- Significant disease of ascending aorta including aneurysm (diameter 50 mm or greater) or atheroma
- Need for urgent or emergent transcatheter aortic valve replacement
- Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device within 30 days prior
- Myocardial infarction within 30 days prior
- Cerebrovascular event (TIA or stroke) within 180 days prior
- Severe stenosis (>70%) of carotid or vertebral arteries
- Severe coagulopathy
- Severe renal insufficiency (GFR <30 ml/min) or need for renal replacement therapy within 180 days prior
- Blood disorders such as leukopenia, thrombocytopenia, or severe anemia
- Active peptic ulcer or upper gastrointestinal bleeding within 90 days prior
- Known allergies to heparin, aspirin, ticlopidine, clopidogrel, nitroglycerin, contrast agents, nitinol, tantalum, or porcine products
- Contraindication to intraoperative transesophageal echocardiography or multi-detector CT scan
- Estimated life expectancy less than 24 months
- Enrollment in another investigational medical device or drug study without completed primary endpoint follow-up
- Other medical, social, or psychological conditions preventing informed consent
- Severe dementia preventing informed consent or compliance
- Inability to comply with follow-up requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China, 215025
Actively Recruiting
2
Fu Wai Hospital, Beijing, China
Beijing, Beijing Municipality, China
Actively Recruiting
3
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Actively Recruiting
4
XiaMen Cardiovascular Hospital XiaMen University
Xiamen, Fujian, China
Actively Recruiting
5
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
6
Nanfang Hospital, Southern Medical University
Guangdong, Guangzhou, China
Actively Recruiting
7
The Second Affiliated Hospital of Harbin Medical University
Haerbin, Heilongjiang, China
Actively Recruiting
8
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Actively Recruiting
9
Wuhan Union Hospital, China
Wuhan, Hubei, China
Actively Recruiting
10
Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
11
Nanjing First Hospital
Nanjing, Jiangsu, China
Actively Recruiting
12
The First Affiliated Hospital of Namchang Umiversity
Nanchang, Jiangxi, China
Actively Recruiting
13
General Hospital of Northern Theater Command
Shenyang, Liaoning, China
Actively Recruiting
14
Qilu Hospital of Shandong University
Jinan, Shandong, China
Actively Recruiting
15
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
16
Xijing Hospital
Xian, Shanxi, China
Actively Recruiting
17
West China Hospital
Chengdu, Sichuan, China
Actively Recruiting
18
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
19
Sir Run Run Shaw Hospital of Zhejiang
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
J
jing ren
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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