Active Post-Market Surveillance of Innovative Devices for Valvular Heart Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement

Transcatheter Edge-to-Edge Repair: Transcatheter Edge-to-Edge Repair

Transcatheter Tricuspid Valve Annuloplasty: Transcatheter Tricuspid Valve Annuloplasty

Surgical Aortic Valve Replacement: Surgical Aortic Valve Replacement

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (1)

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