NCT05202977

Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System

A Prospective，Multicenter, 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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Lepu Medical Technology (Beijing) Co., Ltd. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Transcatheter Aortic Valve Replacement

Interventions

Type	Name	Description
DEVICE	SinocrownTM Transcatheter Aortic Valve Replacement System	Subjects receiving SinocrownTM Transcatheter Aortic Valve Replacement System of Lepu Medical

Timeline

• Start date: 2021-04-06
• Primary completion: 2021-08-07
• Completion: 2026-08-01
• First posted: 2022-01-24
• Last updated: 2022-01-24

Locations

1 site across 1 country: China