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

Aortic Valve Stenosis Clinical Trial

— LOTUS-CHINA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02536703
• Other study ID #: SAHZJU CT005
• Status: Not yet recruiting
• Phase: Phase 3
• First received: August 27, 2015
• Last updated: August 27, 2015
• Start date: September 2015
• Est. completion date: December 2020

Study information

• Verified date: August 2015
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xianbao Liu, MD
• Phone: +86-13857173887
• Email: liuxb2009[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2020
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• Lotus Valve System
Lotus Valve System

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine at Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined rate of death from any cause, myocardial infarction, and stroke	Outcome measures will be defined as suggested by the Valvular Academic Research Consortium (VARC)	30 days following procedure	Yes
Secondary	Number of participants with procedural complications		30 days following procedure	Yes
Secondary	Functional status (NYHA-classification)		6 months following procedure	No
Secondary	Echocardiographic prosthesis status		6 months following procedure	Yes
Secondary	Quality of Life (SF-12)		6 months following procedure	No