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

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country20 target enrollmentSeptember 2015

ConditionsAortic Valve Stenosis

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment: 20
Locations: 1
Primary Endpoint: Combined rate of death from any cause, myocardial infarction, and stroke
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2015

End Date

December 2020

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Responsible Party

Principal Investigator

Jian'an Wang,MD,PhD

President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology

Second Affiliated Hospital, School of Medicine, Zhejiang University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Combined rate of death from any cause, myocardial infarction, and stroke

Time Frame: 30 days following procedure

Outcome measures will be defined as suggested by the Valvular Academic Research Consortium (VARC)

Secondary Outcomes

Number of participants with procedural complications(30 days following procedure)
Quality of Life (SF-12)(6 months following procedure)
Functional status (NYHA-classification)(6 months following procedure)
Echocardiographic prosthesis status(6 months following procedure)