Aortic Valve Stenosis
Conditions
Brief summary
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.
Interventions
DEVICELotus Valve System
Lotus Valve System
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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) 2. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. 3. The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed. 4. Patients are technical and anatomical eligible for interventions
Exclusion criteria
1. 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 2. Subject refuses a blood transfusion. 3. Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent. 4. Native aortic annulus size \< 20 mm or \> 29 mm per the baseline diagnostic imaging. 5. Life expectancy is less than one year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined rate of death from any cause, myocardial infarction, and stroke | 30 days following procedure | Outcome measures will be defined as suggested by the Valvular Academic Research Consortium (VARC) |
Secondary
| Measure | 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 |
Countries
China
Contacts
Primary ContactXianbao Liu, MD
Backup ContactJian-an Wang, MD,PhD
Outcome results
None listed