Aortic Valve Stenosis and Insufficiency
Conditions
Keywords
Aortic Valve Disease, TAVR, Prognosis, Valve durability
Brief summary
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.
Interventions
PROCEDURETranscatheter aortic valve replacement
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
Sponsors
Xijing Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
Patients diagnosed with severe aortic valve regurgitation undergo evaluation by the Heart team and are eligible for TAVR therapy. 2\. Patients who understand the purpose of this study, agree to participate in the trial and sign the informed consent form * 1\. Patients with aortic stenosis or aortic valve insufficiency who were evaluated by the Heart team and underwent TAVR therapy * 2\. Patients who understand the purpose of the study, agree to participate in the trial and sign the informed consent form
Exclusion criteria
* 1\. Patients who cannot provide informed consent * 2\. Patients who are participating in other clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-casuse mortality | 5 years | All-casuse mortality including cardiac death and non-cardiac death |
| Valve-related long-term clinical efficacy | 5 years | * 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of device success | discharge or 30 days | * 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) |
| Combined early safety and clinical efficacy outcomes | 30 days | 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 |
| Valve-related long-term clinical efficacy | 10 years | * 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) |
| Combined clinical efficacy outcomes | 5 years and 10 years | Combined clinical efficacy outcomes as composed by all-cause mortality (cardiac/non-cardiac), all strokes, any hospitalization |
| Rate of technical success | at exit from procedure room | * 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 |
Countries
China
Contacts
Primary ContactRutao Wang, M.D, Ph.D
Outcome results
None listed