Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population (LOTUS-CHINA)

Zhejiang University

Status and phase

Unknown

Phase 3

Conditions

Aortic Valve Stenosis

Treatments

Device: Lotus Valve System

Study type

Interventional

Funder types

Other

Identifiers

NCT02536703

SAHZJU CT005

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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