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This prospective, multicenter, observational cohort study aims to establish a post-market registry framework to evaluate the real-world clinical applicability, long-term safety, and effectiveness of innovative heart valve devices in China.
This prospective, multicenter, observational registry study plans to consecutively enroll patients across 50 Chinese hospitals undergoing treatment with innovative heart valve devices-including transcatheter aortic valve replacement (TAVR), surgical aortic valve replacement (SAVR), transcatheter mitral valve edge-to-edge repair (TEER), and transcatheter tricuspid valve annuloplasty (TTVA) systems. By collecting comprehensive data on medical history, physical examinations, laboratory tests, echocardiography, computed tomography (CT), electrocardiogram (ECG), wearable synchronous electrocardiogram-phonocardiogram, procedural details, pharmacotherapy, as well as regular clinical and imaging follow-up, this study aims to establish a post-market registry framework to evaluate the real-world clinical applicability, long-term safety, and effectiveness of innovative heart valve devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcatheter Aortic Valve Replacement |
| ||
| Transcatheter Edge-to-Edge Repair |
| ||
| Transcatheter Tricuspid Valve Annuloplasty |
| ||
| Device: Surgical Aortic Valve Replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Aortic Valve Replacement | Device | Transcatheter Aortic Valve Replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Up to 1 year post-procedure | |
| Rate of neurologic events | Neurologic events are defined according to VARC-3 criteria, including ischaemic stroke, haemorrhagic stroke, and Transient ischaemic attack (TIA): Ischaemic Stroke: Acute focal neurologic deficit in a vascular territory with symptoms ≥ 24h OR < 24h with neuroimaging (CT or MRI) or pathology confirmation of CNS infarction. Haemorrhagic Stroke: Acute neurologic deficit due to non-traumatic intracranial hemorrhage, confirmed by neuroimaging (CT or MRI) or pathology. TIA: Transient focal neurologic deficit < 24h presumed to be ischaemic, but without evidence of acute infarction on neuroimaging (CT or MRI) or pathology. | Up to 1 year post-procedure |
| Hospitalization | Up to 1 year post-procedure | |
| Bleeding and transfusions | Bleeding events are defined according to VARC-3 criteria: Type 1 (Minor): Overt bleeding that does not require intervention but leads to hospitalization, increased level of care, or medical evaluation, or requires a transfusion of 1 unit of whole blood or red blood cells. Type 2 (Major): Overt bleeding that requires a transfusion of 2 to 4 units of whole blood or red blood cells, or is associated with a hemoglobin drop of 3 to 5 g/dL. Type 3 (Life-threatening or Disabling): Overt bleeding in a critical organ (e.g., intracranial, pericardial with tamponade), causing hypovolemic shock or severe hypotension requiring vasopressors or surgery, or requiring a transfusion of ≥ 5 units of whole blood or red blood cells, or associated with a hemoglobin drop ≥ 5 g/dL. Type 4 (Fatal): Overt bleeding leading to death, classified as probable based on clinical suspicion or definite if confirmed by autopsy or neuroimaging. | Up to 1 year post-procedure |
| Vascular and access-related complications | Periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| Other procedural or valve-related complications | Periprocedural | |
| New conduction disturbances and arrhythmias | Up to 1 year post-procedure | |
| Acute kidney injury |
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Inclusion Criteria:
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Patients with valvular heart disease who have undergone treatment with innovative heart valve replacement or repair systems, including transcatheter aortic valve replacement (TAVR), transcatheter edge-to-edge repair (TEER), and transcatheter tricuspid valve annuloplasty (TTVA), at 50 medical centers in China.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guangyuan Song, MD, PhD | Contact | +86 13801120805 | songgy_anzhen@vip.163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Beijing | Beijing Municipality | 100029 | China |
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| Transcatheter Edge-to-Edge Repair | Device | Transcatheter Edge-to-Edge Repair |
|
| Transcatheter Tricuspid Valve Annuloplasty | Device | Transcatheter Tricuspid Valve Annuloplasty |
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| Surgical Aortic Valve Replacement | Device | Surgical Aortic Valve Replacement |
|
| Cardiac structural complications | Periprocedural |
| Bioprosthetic valve dysfunction | Up to 1 year post-procedure |
| Clinically significant valve thrombosis | Up to 1 year post-procedure |
| Technical success | Technical success is defined according to VARC-3 criteria, requiring the fulfillment of the following:
| Periprocedural |
| Device success | Device success is defined according to VARC-3 criteria, requiring the fulfillment of the following:
| at 30 days |
| Early safety | Taking the Transcatheter Aortic Valve Replacement cohort as an example, early safety is defined according to VARC-3 criteria, requiring the fulfillment of the following:
| at 30 days |
| Clinical efficacy | Taking the Transcatheter Aortic Valve Replacement cohort as an example, clinical efficacy is defined according to VARC-3 criteria, requiring the fulfillment of the following:
| Up to 1 year post-procedure |
| Periprocedural |
| Myocardial infarction | Up to 1 year post-procedure |
| Leaflet thickening and reduced motion | Up to 1 year post-procedure |
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score | Up to 1 year post-procedure |
| New York Heart Association (NYHA) Functional Classification | Class I, II, III, or IV | Up to 1 year post-procedure |
| EuroQol 5-Dimension (EQ-5D) Questionnaire Score | Up to 1 year post-procedure |
| Change in 6-Minute Walk Distance (6MWD) | Up to 1 year post-procedure |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D001022 | Aortic Valve Insufficiency |
| D008944 | Mitral Valve Insufficiency |
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| 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 |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |
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