NCT07304427

Alwide Plus China Post-market Clinical Investigation

A Prospective, Multicenter, Post-market Clinical Investigation to Evaluate the Pre-dilation Safety and Effectiveness of Alwide Plus Balloon Catheter of MicroPort CardioFlow in Transcatheter Aortic Valve Replacement

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 75 (actual)
• Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, multi-center, post-market registry study conducted in China. The purpose is to evaluate the safety and effectiveness of the AlwideTM Plus balloon catheter for pre-dilatation of the aortic valve during TAVR in the real-world setting.

Detailed description

The study is designed to evaluate the safety and effectiveness of the Alwide Plus balloon catheter for pre-dilatation of the aortic valve during in transcatheter aortic valve replacement in the real-world setting, with TAVI device success at immediate post-procedure as the primary endpoint. The immediate post-procedural pre-dilation success, all-cause mortality, stroke, bleeding, acute kidney injury, permanent pacemaker implantation, major vascular complication, valve function at post-procedure and discharge, and post-dilation success will be used as secondary endpoints.This is a prospective, multi-center, post market clinical investigation. 75 patients will be enrolled in this clinical investigation. All subjects will undergo telephone follow-up at 30 days post-procedure.

Conditions

• Severe Aortic Stenosis
• Transcatheter Aortic Valve Replacemen

Timeline

• Start date: 2025-01-03
• Primary completion: 2025-10-11
• Completion: 2025-11-04
• First posted: 2025-12-26
• Last updated: 2025-12-26

Locations

4 sites across 1 country: China