Alwide Plus China Post-market Clinical Investigation

MicroPort

Status: Completed

Conditions: Severe Aortic Stenosis; Transcatheter Aortic Valve Replacemen

Study type: Observational

Funder types: Industry

Identifiers

NCT07304427

Alwide Plus-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

75 participants in 1 patient group

Alwide Plus

Description:

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