To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis
Key facts
- Where
- Beijing, ChinaSee the site
Where in China
- Fuwai Hospital ，CAMS&PUMCBeijing, ChinaContact: Yongjian WuTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Chengdu Silara Meditech Inc.
- Trial code
- NCT04893603
- Record updated
- 19 May 2021
- Original description
To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Aortic Stenosis with or without Moderate or Lower Degree RegurgitationRead full original descriptionShow less
A Prospective, Multi-center, Single-arm Clinical Trial to Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis With or Without Moderate or Lower Degree Regurgitation
To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Aortic Stenosis with or without Moderate or Lower Degree Regurgitation
Inclusion: Age ≥70 years old; Symptomatic severe aortic stenosis determined by echocardiogram, defined as: mean gradient ≥40 mmHg or peak jet velocity ≥4.0 m/s, or an aortic valve area <0.8 cm2 or aortic valve area index <0.5 cm2/m2; NYHA Functional Class ≥II; Life expectancy after aortic valve implantation thought to be >1 year; Native valvular or peripheral vascular anatomy is appropriate for TAVR; Patient is assessed by at least two cardiothoracic surgeons and recorded as not suitable for surgery; Patient can understand the purpose of the study, voluntarily participates and signs the informed consent form and is willing to accept the relevant examination and clinical follow-up visits.
Exclusion: Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization); Active pepticulcer or upper GI bleeding within 3 months prior to the study procedure; Cerebral Vascular Accident (CVA) within 3 months prior to the study procedure, including TIA; Currently participating in an investigational drug or another device trial; Pre-existing prosthetic valve in any position(except severely dysfunctional aortic bioprosthesis), or severe (>3+) mitral insufficiency, or Gorlin syndrome; Hemodynamic unstable requiring myocardial contractile support or mechanical cardiac assistance; Echocardiographic evidence of intra-cardiac thrombus or vegetation etc; A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, or sensitivity to contrast media, which cannot be adequately pre-medicated; Patients with infective endocarditis or other active stage of infection; Evidence of an acute myocardial infarction within 30 days prior to the study procedure, defined as: Q-wave myocardial infarction, or non-Q-wave myocardial infarction, with CK-MB≥2 ULN/or elevated TN (WHO definition); Hematological abnormality, defined as: Leukopenia (WBC <3x10\^9/L), acute anemia (Hb <90g/L), or thrombocytopenia (platelet count<50×109/L),history of bleeding diathesis or coagulopathy; Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) <20%; Anatomy is not appropriate for percutaneous valve implantation. Native valve annulus diameter is not in the scope of application(native TAV diameter ≤21mm, or ≥30mm).