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The study aimed to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in patients with severe native valve aortic insufficiency. It is a multicentre, observational cohort study. The primary endpoint consisted of a composite of all-cause death, disabling stroke, or rehospitalization for heart failure at 12 months postoperatively. According to previous research results and opinions of expert groups, the sample size was expected to be 76 cases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVR group | The group that undergoes transcatheter aortic valve replacement |
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| Measure | Description | Time Frame |
|---|---|---|
| all-cause mortality | Death caused by any reason | 12 months |
| Disabling stroke | Stroke that results in a disabled state | 12 months |
| Rehospitalization for heart failure | Rehospitalization for heart failure | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device success | Absence of procedural mortality AND Correct positioning of a single prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (no prosthesis- patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation) | intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with severe aortic regurgitation undergo transcatheter aortic valve replacement in medical centers
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ruqiong nie | Contact | +86 13600479016 | nieruqiong@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510123 | China |
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| ID | Term |
|---|---|
| D001022 | Aortic Valve Insufficiency |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Perioperative complications | Perioperative complications conclude Life-threatening bleeding, Acute kidney injury-Stage 2 or 3 (including renal replacement therapy), Coronary artery obstruction requiring intervention, Major vascular complications, and Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR) | up to 1 week |
| New permanent pacemaker implantation(PPI) | New PPI indications:
| up to 1 week |
| New complete left bundle branch block(CLBBB) | Diagnostic criteria are defined as follows:
| up to 1 week |
| Valve-related dysfunction | Mean aortic valve gradient ≥20 mmHg, EOA ≤0.9-1.1 cm and DVI <0.35 m/s, and/or moderate or severe prosthetic valve regurgitation, and/or Prosthetic valve endocarditis, and/or Prosthetic valve thrombosis | 12 months |
| NYHA class Ill or IV | The New York Heart Association (NYHA) class Ill or IV | 12 months |