Aortic Regurgitation, Aortic Stenosis, Mitral Regurgitation, Tricuspid Regurgitation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICETranscatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement
Transcatheter Edge-to-Edge Repair
DEVICETranscatheter Tricuspid Valve Annuloplasty
Transcatheter Tricuspid Valve Annuloplasty
Surgical Aortic Valve Replacement
Sponsors
Beijing Anzhen Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with valvular heart disease (VHD) receiving treatment with prosthetic aortic valve replacement systems (transcatheter and surgical valves), transcatheter mitral valve edge-to-edge repair (TEER) systems, or transcatheter tricuspid valve annuloplasty systems * Age ≥ 18 years * Patients who voluntarily participate in the study and sign the informed consent form * Willing and able to comply with follow-up requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Up to 1 year post-procedure | — |
| Rate of neurologic events | Up to 1 year post-procedure | 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. |
| Hospitalization | Up to 1 year post-procedure | — |
| Bleeding and transfusions | Up to 1 year post-procedure | 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. |
| Vascular and access-related complications | Periprocedural | — |
| 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 | Periprocedural | 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. |
| Device success | at 30 days | 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 |
| Early safety | at 30 days | 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 |
| Clinical efficacy | Up to 1 year post-procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other procedural or valve-related complications | Periprocedural | — |
| New conduction disturbances and arrhythmias | Up to 1 year post-procedure | — |
| Acute kidney injury | 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 | Up to 1 year post-procedure | Class I, II, III, or IV |
| 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 | — |
Countries
China
Contacts
CONTACTGuangyuan Song, MD, PhD
Outcome results
None listed