NCT05391191

Safety and Feasibility of TRISKELE in Severe AS

Prospective Clinical Study on the Safety and Clinical Feasibility of Exploring TRISKELE® Transcatheter Aortic Valve System in the Treatment of Severe Aortic Stenosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

This clinical study is a prospective、single arm and exploratory study, to explore the feasibility and safety of MitrAssist TRISKELE® transcatheter aortic valve system in the treatment of patients with severe aortic stenosis.

Detailed description

This study was a prospective、single arm clinical trial design. For patients with surgical contraindications or high-risk symptomatic severe aortic stenosis, MitrAssist TRISKELE® transcatheter aortic valve system was performed by aortic valve replacement. Patients were followed up 30 days (± 7 days) after operation for the feasibility and safety analysis to explore the test device in patients with surgical contraindications or high-risk symptomatic severe aortic stenosis.In this study, a clinical trial institution meeting the national qualification is planned to be selected as the clinical research center, and 7 patients are planned to be selected. The success rate of operation 30 days after operation was taken as the main evaluation index and the success of device implantation, the result of echocardiography evaluation of valve function, the improvement rate of NYHA cardiac function classification, six minute walking distance and the score of Kansas City Cardiomyopathy Questionnaire were taken as the secondary evaluation indexes, to evaluate clinical effectiveness of TRISKELE® transcatheter aortic valve system; Adverse events, serious adverse events, major cardiovascular and cerebrovascular adverse events, device defects, vital signs and laboratory examination results were used as safety indicators to evaluate the safety of the test device .

Conditions

• Aortic Valve Disease

Interventions

Type	Name	Description
DEVICE	MitrAssist TRISKELE® transcatheter aortic valve system	Patients were treated with MitrAssist TRISKELE® transcatheter aortic valve system

Timeline

• Start date: 2022-07-06
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2022-05-25
• Last updated: 2022-07-12

Locations

1 site across 1 country: China