Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population

Study Overview
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Brief Summary
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To confirm the safety and efficacy of the Lotus™ Valve System in the Chinese population for Transcatheter Aortic Valve Implantation (TAVI) in symptomatic patients with severe aortic stenosis.

Official Title
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LOTUS-CHINA: Safety and Efficacy of Lotus Valve For Transcatheter Aortic Valve Implantation In Patients With Severe Aortic Stenosis In Chinese Population

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: Lotus Valve System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with symptomatic severe aortic stenosis (echocardiographic criteria: AV effective orifice area (EOA) of < 1 cm2, mean AV gradient of > 40 mmHg, or AV peak systolic velocity of > 4.0 m/s; NYHA-class II or greater, angina pectoris, or syncope) Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed. Patients are technical and anatomical eligible for interventions 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lotus Valve System<br>Transcatheter Aortic Valve Implantation (TAVI) with Lotus Valve System | Device: Lotus Valve System<br>* Lotus Valve System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 6 months following procedure | 
| Quality of Life (SF-12) |  | 6 months following procedure |