Alwide Plus China Post-market Clinical Investigation

NCT07304427 | Completed

• 1 other identifier: Alwide Plus-2024
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Percentage of patients with balloon pre-dilation success

  Immediate post-procedure

• Percentage of paitents with balloon post-dilation success

  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

  Immediate post-procedure and 30 days post-procedure

• Prosthetic valve performance-mean transvalular pressure gradient

  Immediate post-procedure and discharge(within 7 days post-procedure)

• Prosthetic valve performance-orifice area

  Immediate post-procedure and discharge(within 7 days post-procedure)

Study Arms (1)

Alwide Plus

Paitents perfomed TAVR and have Alwlide Plus Balloon Catheter pre-dilaton or post-dilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (4)

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

Location

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

Location

Yan'an Hospital of Kunming City

Kunming, Yunnan, China

Location

Guangdong Provincial People's Hospital

Guangzhou, China

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 26, 2025
• Study Start: January 3, 2025
• Primary Completion: October 11, 2025
• Study Completion: November 4, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)