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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter aortic valve replacement | Procedure | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-casuse mortality | All-casuse mortality including cardiac death and non-cardiac death | 5 years |
| Valve-related long-term clinical efficacy |
| 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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
Exclusion Criteria:
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Consecutive patients with severe aortic stenosis or valve regurgitation undergo transcatheter aortic valve replacement (TAVR) following evaluation by a cardiac team.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rutao Wang, M.D, Ph.D | Contact | +86-15091095796 | rutaowang@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Ling Tao, M.D, Ph.D | Xijing Hospital | Study Chair |
| Rutao Wang, M.D, Ph.D | Xijing Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Recruiting | Xi'an | Shannxi | 710032 | China |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| 30 days |
| Rate of technical success |
| at exit from procedure room |
| Rate of device success |
| 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 | 5 years and 10 years |
| Valve-related long-term clinical efficacy |
| 10 years |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |