This registry aims to evaluate the long-term prognosis and valve durability of transcatheter aortic valve replacement (TAVR) in a real-world setting. Baseline characteristics, procedural data, and clinical outcomes will be collected in a prospective and observational manner.
Study Type
OBSERVATIONAL
Enrollment
1,000
A total of 1000 consecutive patients with aortic valve disease undergoing TAVR will be enrolled. Clinical follow-up will be conducted in the periprocedural and after TAVR at 1 month, 5 years, and 10 years
Xijing Hospital
Xi'an, Shannxi, China
RECRUITINGAll-casuse mortality
All-casuse mortality including cardiac death and non-cardiac death
Time frame: 5 years
Valve-related long-term clinical efficacy
* Freedom from bioprosthetic Valve Failure (defined as: Valve- related mortality OR Aortic valve re-operation/re-intervention OR Stage 3 hemodynamic valve deterioration * Freedom from stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies) * Freedom from VARC Type 2-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents, used specifically for valve-related concerns (e.g. clinically apparent leaflet thrombosis)
Time frame: 5 years
Combined early safety and clinical efficacy outcomes
Composed by all-cause mortality, all strokes, life-threatening or fatal bleeding, major vascular, access-related, or cardiac structural complication, acute kidney injury stage 3 or 4, moderate or severe aortic regurgitation, new permanent pacemaker due to procedure-related conduction abnormalities, conduction block and arrhythmia, surgery or intervention related to the device, any hospitalization, myocardial infarction, any other adverse events
Time frame: 30 days
Rate of 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 device or to a major vascular or access-related, or cardiac structural complication
Time frame: at exit from procedure room
Rate of 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, and less than moderate aortic regurgitation)
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Time frame: discharge or 30 days
Combined clinical efficacy outcomes
Combined clinical efficacy outcomes as composed by all-cause mortality (cardiac/non-cardiac), all strokes, any hospitalization
Time frame: 5 years and 10 years
Valve-related long-term clinical efficacy
* Freedom from bioprosthetic Valve Failure (defined as: Valve- related mortality OR Aortic valve re-operation/re-intervention OR Stage 3 hemodynamic valve deterioration * Freedom from stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies) * Freedom from VARC Type 2-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents, used specifically for valve-related concerns (e.g. clinically apparent leaflet thrombosis)
Time frame: 10 years