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

Phase 3

• Conditions: Aortic Valve Stenosis
• Interventions: Device: Lotus Valve System

• Registration Number: NCT02536703
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-08
• Study First Submitted: 2015-08-27
• Study First Submitted QC: 2015-08-27
• Last Update Submitted: 2015-08-27
• Study Start: 2015-09
• Study First Posted: 2015-09-01
• Last Update Posted: 2015-09-01
• Primary Completion: 2015-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lotus Valve System	Lotus Valve System	Transcatheter Aortic Valve Implantation (TAVI) with Lotus Valve System

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine at Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China