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To confirm the safety and efficacy of the Lotusâ„¢ Valve System in the Chinese population for Transcatheter Aortic Valve Implantation (TAVI) in symptomatic patients with severe aortic stenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lotus Valve System | Experimental | Transcatheter Aortic Valve Implantation (TAVI) with Lotus Valve System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotus Valve System | Device | Lotus Valve System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined rate of death from any cause, myocardial infarction, and stroke | Outcome measures will be defined as suggested by the Valvular Academic Research Consortium (VARC) | 30 days following procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with procedural complications | 30 days following procedure | |
| Functional status (NYHA-classification) | 6 months following procedure | |
| Echocardiographic prosthesis status |
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Inclusion Criteria:
Exclusion Criteria:
A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:
Aspirin Heparin (HIT/HITTS) and bivalirudin Nitinol (titanium or nickel) Ticlopidine and clopidogrel Contrast media
Subject refuses a blood transfusion.
Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
Native aortic annulus size < 20 mm or > 29 mm per the baseline diagnostic imaging.
Life expectancy is less than one year
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianbao Liu, MD | Contact | +86-13857173887 | liuxb2009@hotmail.com | |
| Jian-an Wang, MD,PhD | Contact | +86-13805786328 | Wang_jian_an@tom.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian-an Wang, MD,PhD | Second Affiliated Hospital Zhejiang University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Affiliated Hospital, School of Medicine at Zhejiang University | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 6 months following procedure |
| Quality of Life (SF-12) | 6 months following procedure |
| D014694 |
| Ventricular Outflow Obstruction |