The purpose of this prospective multi-center, observational registry in China is to collect clinical baseline, procedural, and follow-up data of all patients treated with TAVR in China and to evaluate short-, mid-, and long-term clinical outcome data of all post-marketing transcatheter valves. Each center will collect baseline and procedural data as well as clinical outcomes for up to 10 years.
Patients with aortic valve disease are evaluated by the cardiac team and indicate TAVR therapy
Patients who understand the purpose of this study, voluntarily participate in the trial and sign the informed consent form
Patients with aortic valve disease who have been evaluated by a cardiac team as unsuitable for TAVR
Patients who cannot tolerate the materials or medications associated with this study
Women who are pregnant or breastfeeding
Patients who participated in a clinical trial of another drug or medical device before enrollment
Consecutive patients with aortic valve disease who are evaluated by the cardiac team for TAVR treatment
Cohort
Prospective
Transcatheter aortic valve replacement
Procedure/SurgeryA total of 3000 consecutive patients with aortic valve disease undergoing TAVR will be enrolled at 30-50 centers. The devices used will be all post-market transcatheter aortic valves approved for use in China. Clinical follow-up will be conducted in the periprocedural and after aortic valve implantation at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years
Combined early safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3)
Composed by all-cause mortality, all strokes, any hospitalization, myocardial infarction
Combined early safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3)
Composed by all-cause mortality, all strokes, any hospitalization, myocardial infarction, acute kidney injury, life-threatening or fatal bleeding, mild or greater prosthetic valve regurgitation, new permanent pacemaker implantation, conduction block and arrhythmia, vascular and access-related complications, structural cardiac complications, any other adverse events
Rate of technical success
Technical success * Freedom from mortality * Successful access, delivery of the device, and retrieval of the delivery system * Correct positioning of a single prosthetic heart valve into the proper anatomical location * Freedom from surgery or intervention related to the devicea or to a major vascular or access-related, or cardiac structural complication
Rate of device success
Device success * Technical success * Freedom from mortality * Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication * Intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3 m/s, Doppler velocity index \>\_0.25, and less than moderate aortic regurgitation)
Combined safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3)
Composed by all-cause mortality, all strokes, any hospitalization, myocardial infarction, life-threatening or fatal bleeding, mild or greater prosthetic valve regurgitation, new permanent pacemaker implantation, conduction block and arrhythmia, any other adverse events
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