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.
Study Type
OBSERVATIONAL
Enrollment
5,500
Transcatheter Aortic Valve Replacement
Transcatheter Edge-to-Edge Repair
Transcatheter Tricuspid Valve Annuloplasty
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Mortality
Time frame: 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.
Time frame: Up to 1 year post-procedure
Hospitalization
Time frame: 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.
Time frame: Up to 1 year post-procedure
Vascular and access-related complications
Time frame: Periprocedural
Cardiac structural complications
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Surgical Aortic Valve Replacement
Time frame: Periprocedural
Bioprosthetic valve dysfunction
Time frame: Up to 1 year post-procedure
Clinically significant valve thrombosis
Time frame: Up to 1 year post-procedure
Technical success
Technical success is defined according to VARC-3 criteria, requiring the fulfillment of the following: 1. Freedom from mortality. 2. Successful access, delivery of the device, and retrieval of the delivery system. 3. Correct positioning of a single prosthetic heart valve into the proper anatomical location. 4. Freedom from surgery or intervention related to the device, or to a major vascular, access-related, or cardiac structural complication.
Time frame: Periprocedural
Device success
Device success is defined according to VARC-3 criteria, requiring the fulfillment of the following: 1. Technical success 2. Freedom from mortality 3. Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication 4. Intended performance of the valve
Time frame: 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: 1. Freedom from all-cause mortality 2. Freedom from all stroke 3. Freedom from VARC type 2-4 bleeding 4. Freedom from major vascular, access-related, or cardiac structural complication 5. Freedom from acute kidney injury stage 3 or 4 6. Freedom from moderate or severe aortic regurgitation 7. Freedom from new permanent pacemaker due to procedure-related conduction abnormalities 8. Freedom from surgery or intervention related to the device
Time frame: 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: 1. Freedom from all-cause mortality 2. Freedom from all stroke 3. Freedom from hospitalization for procedure- or valve-related causes 4. Freedom from KCCQ Overall Summary Score \<45 or decline from baseline of \>10 point
Time frame: Up to 1 year post-procedure
Other procedural or valve-related complications
Time frame: Periprocedural
New conduction disturbances and arrhythmias
Time frame: Up to 1 year post-procedure
Acute kidney injury
Time frame: Periprocedural
Myocardial infarction
Time frame: Up to 1 year post-procedure
Leaflet thickening and reduced motion
Time frame: Up to 1 year post-procedure
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
Time frame: Up to 1 year post-procedure
New York Heart Association (NYHA) Functional Classification
Class I, II, III, or IV
Time frame: Up to 1 year post-procedure
EuroQol 5-Dimension (EQ-5D) Questionnaire Score
Time frame: Up to 1 year post-procedure
Change in 6-Minute Walk Distance (6MWD)
Time frame: Up to 1 year post-procedure