NCT06721676

Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis

A Prospective, Single-center, Single-group Follow-up Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis by Peijia Medical

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Peijia Medical Technology (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medical

Detailed description

A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medica.Patients are seen at pre and post procedure, discharge, 30 days. The main follow-up included clinical symptoms and signs, cardiac ultrasound, CT, etc. The outcome include immediate device success, procedure success and device sucess. The secondary end points include ：1) Immediate postoperative ultrasound evaluation of different sinus valve implantation depths.2) realization rate of commissural alignment was evaluated by ultrasound immediately after operation.3) the incidence of ≥ moderate paravalvular regurgitation assessed by ultrasound at 30 days after surgery. 4\) CT assessment of different sinus valve implantation depths at 30 days after surgery.5) CT was performed 30 days after operation to evaluate the realization rate of commissural alignment and coronary artery alignment

Conditions

• Aortic Stenosis Symptomatic

Interventions

Type	Name	Description
DEVICE	transcatheter aortic valve replacement in severe aortic stenosis	transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-05-31
• Completion: 2025-06-30
• First posted: 2024-12-06
• Last updated: 2024-12-06

Locations

1 site across 1 country: China