ArcFlex Sheath in TAVR Trial

Inclusion criteria

• Judged by a professional cardiologist to require TAVR surgery
• NYHA ≥ II grade
• Evaluated by the cardiac team, the peripheral vascular approach is suitable for performing the surgery via the femoral route
• Expected lifespan is greater than 1 year (5) Patients who can understand the purpose of the trial, voluntarily participate, sign the informed consent form, and are willing to undergo relevant examinations and clinical follow-ups.

Exclusion criteria

• Presence of other valvular diseases requiring concurrent intervention.
• Anatomical characteristics unsuitable for transcatheter valve implantation.
• Severe mitral stenosis due to organic causes requiring surgical valve replacement or repair.
• Hypertrophic obstructive cardiomyopathy (unexplained myocardial hypertrophy >1.5 cm).
• Acute myocardial infarction within the past 30 days.
• Intracardiac mass, thrombus, or vegetation indicated by echocardiography.
• Active infective endocarditis or any other active infection.
• Intolerance to tolerate anticoagulant or antiplatelet therapy.
• Coagulopathy or refusal to receive blood transfusion therapy.
• Known allergy to device materials or contrast agents.
• Acute peptic ulcer or gastrointestinal bleeding within the past 3 months.
• Stroke or transient ischemic attack (TIA) within the past 3 months.
• Requirement for emergency surgical treatment for any reason.
• Expected life expectancy of less than 12 months due to non-cardiac causes.
• Severe disabling dementia or inability to perform activities of daily living.
• Participation in other clinical trials of drugs or medical devices prior to enrollment and not yet reached the primary endpoint of that study.