NCT07392359

Zhicheng TAVR Robot

Prospective, Multicentre, Randomised Controlled, Non-Inferiority Clinical Trial Evaluating the Safety and Efficacy of the TAVR Assist System and Its Disposable Kit for Use as an Adjunct to TAVR

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Zhicheng Medical Technology (Jiaxing) Co, Ltd · Industry
• Sex: All
• Age: 65 Years – 100 Years
• Healthy volunteers: Accepted

Summary

Use of the Transcatheter Aortic Valve Replacement Surgical Assist System and its Disposable Kit in Patients With Severe Aortic Stenosis to Evaluate the Safety and Efficacy of the Transcatheter Aortic Valve Replacement Surgical Assist System and its Disposable Kit for Use as an Adjunct to Transcatheter Aortic Valve Replacement

Conditions

• Aortic Stenosis Treated With TAVI

Interventions

Type	Name	Description
DEVICE	TAVR Assistance System	Whether or not TAVR procedures are performed with a TAVR assist system
OTHER	TAVR by manual	TAVR by manual

Timeline

• Start date: 2026-02-15
• Primary completion: 2026-10-15
• Completion: 2026-10-15
• First posted: 2026-02-06
• Last updated: 2026-02-06