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

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.

Study Overview

• Status: Completed
• Conditions: Severe Aortic Stenosis; Transcatheter Aortic Valve Replacemen

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.

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • Guangdong Provincial People's Hospital
  • Guangdong
    • Zhanjiang, Guangdong, China
      • Affiliated Hospital of Guangdong Medical University
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Jiangxi Provincial People's Hospital
  • Yunnan
    • Kunming, Yunnan, China
      • Yan'an Hospital of Kunming City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering severe aortic stenosis and requiring pre-dilation during TAVR

Description

Inclusion Criteria:

• Age≥18 years old;
• Severe aortic stenosis verified by echocardiogram: mean transvalvular gradient≥40mmHg (1mmHg=0.133kPa), or peak aortic jet velocity≥4m/s, or aortic valve area (AVA) ≤ 1.0cm2 (or AVA index≤ 0.6cm2/m2);
• Patients, who can understand the clinical investigation purpose, voluntary agree and sign the informed consent form, and willing to comply with relevant trial assessments and clinical follow up

Exclusion Criteria:

• Aortic valve anatomy or lesion unsuitable or not necessary for balloon pre-dilation during the TAVR procedure
• TAVR procedure in trans-apical access
• Pre-implanted mechanical or bioprosthetic valve at the aortic valve position
• Acute myocardial infarction (MI) occurred in the last 30 days before the treatment；
• LVOT obstruction;
• Serious left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%
• Echocardiographic evidence of intracardiac mass, thrombus or neoplasm；
• Unable to receive anticoagulation or antiplatelet therapy；
• Allergy to nitinol or sensitive contrast media；
• Active bacterial endocarditis or other active infection may affect the procedure；
• Aortic valve anatomy , lesion, or other situation unsuitable for the prosthesis valve implantation as assessed by the investigator team；
• Life expectancy > 12 months；
• vulnerable individuals who are unable to give informed consent/ unable to fully understand all aspects of the investigation or Severe incapacitating Alzheimer's disease；
• Patients who participated in other clinic trials of drugs or medical device before being enrolled for which the primary endpoint follow up duration has not been reached；
• Investigators determined that patients have poor compliance and can't complete the study as required

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Alwide Plus; Paitents perfomed TAVR and have Alwlide Plus Balloon Catheter pre-dilaton or post-dilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with TAVI device success at immediate post-procedure	TAVI device success, defined as (meeting all the following criteria): Freedom from mortality; Successful access, delivery, deployment, implantation of the valve, and retrieval of the delivery system; Correct positioning of the prosthetic heart valve into the proper anatomical location; Intended performance of the valves (mean gradient <20mmHg, or peak velocity <3 m/s, and no severe aortic regurgitation or paravalvular leakage).	Immediate post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with balloon pre-dilation success	defined as successful access, delivery and dilation the aortic valve, and retrieval for the AlwideTM Plus balloon catheter	Immediate post-procedure
Percentage of paitents with balloon post-dilation success	defined as successful access, delivery and dilation the transcatheter aortic valve, and retrieval for the AlwideTM Plus balloon catheter	Immediate post-procedure
Incidence of all-cause mortality, disabling and non-disabling stroke, life-threatening or disabling bleeding, major bleeding, acute kidney injury(AKIN≥2), major vascular complications and new permanent pacemaker implantation	Definition following VARC-2 criteria	Immediate post-procedure and 30 days post-procedure
Prosthetic valve performance-mean transvalular pressure gradient	Prosthetic valve performance-mean pressure gradient(assessed by echocardiography), unit -mmHg	Immediate post-procedure and discharge(within 7 days post-procedure)
Prosthetic valve performance-orifice area	Prosthetic valve performance-orifice area(assessed by echocardiography), unit -cm2	Immediate post-procedure and discharge(within 7 days post-procedure)
Prosthetic valve performance-valve regurgitation(intra- and para valvular leakage)	Prosthetic valve performance-valve regurgitation(intra- and para valvular leakage), none/trace/mild/moderate/severe	Immediate post-procedure and discharge(within 7 days post-procedure)

Collaborators and Investigators

• Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2025
• Primary Completion (Actual): October 11, 2025
• Study Completion (Actual): November 4, 2025

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: Alwide Plus-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No