Alwide Plus China Post-market Clinical Investigation (NCT07304427) | Clinical Trial Compass
CompletedNot Applicable
Alwide Plus China Post-market Clinical Investigation
China75 participantsStarted 2025-01-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 treatmentï¼›
* LVOT obstruction;
* Serious left ventricular dysfunction with left ventricular ejection fraction (LVEF) \<20%
* Echocardiographic evidence of intracardiac mass, thrombus or neoplasmï¼›
* Unable to receive anticoagulation or antiplatelet therapyï¼›
* Allergy to nitinol or sensitive contrast mediaï¼›
* Active bacterial endocarditis or other active infection may affect the procedureï¼›
* Aortic valve anatomy , lesion, or other situation unsuitable for the prosthesis valve implantation as assessed by the investigator teamï¼›
* Life expectancy \> 12 monthsï¼›
* vulnerable individuals who are unable to give informed consent/ unable to fully understand all aspects of the investigation or Severe incapacitating Alzheimer's disease…
What they're measuring
1
Percentage of patients with TAVI device success at immediate post-procedure