Brief Title
Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population
Official Title
LOTUS-CHINA: Safety and Efficacy of Lotus Valve For Transcatheter Aortic Valve Implantation In Patients With Severe Aortic Stenosis In Chinese Population
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Combined rate of death from any cause, myocardial infarction, and stroke
Secondary Outcome
Number of participants with procedural complications
Condition
Aortic Valve Stenosis
Intervention
Lotus Valve System
Study Arms / Comparison Groups
Lotus Valve System
Description: Transcatheter Aortic Valve Implantation (TAVI) with Lotus Valve System
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
20
Start Date
September 2015
Completion Date
December 2020
Primary Completion Date
December 2015
Eligibility Criteria
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
Gender
All
Ages
65 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jian-an Wang, MD,PhD, +86-13857173887, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02536703
Organization ID
SAHZJU CT005
Responsible Party
Principal Investigator
Study Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor
Jian-an Wang, MD,PhD, Principal Investigator, Second Affiliated Hospital Zhejiang University School of Medicine
Verification Date
August 2015