Alwide Plus China Post-market Clinical Investigation
NCT07304427 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 75
Last updated 2025-12-26
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.
Conditions
- Severe Aortic Stenosis
- Transcatheter Aortic Valve Replacemen
Sponsors & Collaborators
-
Shanghai MicroPort CardioFlow Medtech Co., Ltd.
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-03
- Primary Completion
- 2025-10-11
- Completion
- 2025-11-04
Countries
- China
Study Locations
More Related Trials
-
Clinical Trial in China for Aortic Valve Stenosis
NCT05607667 ·Status: COMPLETED ·Phase: NA
-
China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population
NCT03314857 ·Status: COMPLETED ·Phase: NA
-
A Prospective, Multicenter, Observational Study of the Safety and Efficacy of Emergency Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis
NCT07108478 ·Status: NOT_YET_RECRUITING
-
Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China
NCT06830499 ·Status: RECRUITING
-
Transaxillary TAVR With Solely Echocardiography Guidance
NCT07035847 ·Status: RECRUITING ·Phase: NA
-
Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China
NCT04988243 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Coronary Crossing System in Patients With Coronary Chronic Total Occlusions
NCT05813704 ·Status: RECRUITING ·Phase: NA
-
Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
NCT01445171 ·Status: COMPLETED ·Phase: NA
-
Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation With Balloon-expandable Valves Versus Self-expandable Valves.
NCT03588247 ·Status: COMPLETED
-
The Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients With Bicuspid Aortic Stenosis
NCT03163329 ·Status: UNKNOWN ·Phase: PHASE2
-
Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve
NCT07097740 ·Status: RECRUITING ·Phase: NA
-
Echo-Guided vs Fluoroscopy-Guided Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis(ECHO-TAVR)
NCT07317804 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
A Prospective, Multicenter, Single-arm Study to Evaluate a Transcatheter Aortic Valve System Safety and Efficacy for the Treatment of Patients With Severe Aortic Stenosis
NCT06136429 ·Status: RECRUITING ·Phase: NA
-
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
NCT01700439 ·Status: COMPLETED ·Phase: NA
-
Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation
NCT04864145 ·Status: RECRUITING ·Phase: NA
-
Portico Next Generation Approval Study
NCT04011722 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation
NCT06381271 ·Status: RECRUITING
-
Outcomes for Patients With Ascending Aortic Dilation Who Underwent TAVR
NCT07148973 ·Status: COMPLETED
-
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve Replacement System With Retrievable Delivery Catheter System
NCT04744857 ·Status: COMPLETED ·Phase: NA
-
Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis
NCT06721676 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial
NCT01419015 ·Status: COMPLETED ·Phase: NA
-
Safety and Efficacy of Post-marketing Transcatheter Aortic Valves in "Real World" Chinese Patients
NCT06257043 ·Status: RECRUITING
-
Hemodynamic Matched Comparison of the Balloon-Expandable Transcatheter Heart Valves Myval and Sapien-3 for the Treatment of Aortic Stenosis
NCT04548726 ·Status: COMPLETED
-
5 Year Observation of Patients With PORTICO Valves
NCT01802788 ·Status: COMPLETED
-
Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement
NCT00584116 ·Status: COMPLETED