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Alwide Plus China Post-market Clinical Investigation

NCT ID: NCT07304427

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-03

Study Completion Date

2025-11-04

Brief Summary

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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

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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

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Severe Aortic Stenosis Transcatheter Aortic Valve Replacemen

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Alwide Plus

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai MicroPort CardioFlow Medtech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

Site Status

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

Site Status

Yan'an Hospital of Kunming City

Kunming, Yunnan, China

Site Status

Guangdong Provincial People's Hospital

Guangzhou, , China

Site Status

Countries

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China

Other Identifiers

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Alwide Plus-2024

Identifier Type: -

Identifier Source: org_study_id