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Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System

Transcatheter Aortic Valve Replacement Clinical Trial

Official title:
A Prospectiveļ¼ŒMulticenter, Single-arm Clinical Trial to Evaluate Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System With Accessories in Patients With Symptomatic, Calcified and Severe Aortic Stenosis

Clinical Trial Summary

This study was designed to preliminary verify the safety and of efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System With accessories in patients with symptomatic, calcified and severe aortic stenosis using objective performance criteria

Clinical Trial Description

This prospective, single-center, single-arm clinical trial was designed to preliminary confirm the safety and efficacy of SinocrownTM transcatheter aortic valve system with accessories. According to the inclusion and exclusion criteria, 10 patients were enrolled and implanted with SinocrownTM .Patients will been followed up 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after valve implantation. The main follow-up included clinical symptoms and signs, cardiac ultrasound, etc. The primary endpoint was device success after TAVR, Secondary endpoints included procedural success, all-cause mortality, myocardial infarction, disabling stroke, severe bleeding, acute kidney injury, permanent pacemaker implantation, vascular complications, other complication, MACCEs, valvular function , cardiac function improvement, quality of life of patients. ;

Study Design

Related Conditions & MeSH terms

  • Transcatheter Aortic Valve Replacement
Clinical Trial Details
NCT number NCT05202977
Study type Interventional
Source Lepu Medical Technology (Beijing) Co., Ltd.
Contact
Status Enrolling by invitation
Phase N/A
Start date April 6, 2021
Completion date August 2026
View Details
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