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

ConditionsAortic StenosisAortic RegurgitationMitral RegurgitationTricuspid Regurgitation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Transcatheter Aortic Valve Replacement

    Device

    Transcatheter Aortic Valve Replacement

  • Transcatheter Edge-to-Edge Repair

    Device

    Transcatheter Edge-to-Edge Repair

  • Transcatheter Tricuspid Valve Annuloplasty

    Device

    Transcatheter Tricuspid Valve Annuloplasty

  • Surgical Aortic Valve Replacement

    Device

    Surgical Aortic Valve Replacement

Treatment groups

5,500 Participants
are divided into 4 treatment groups
Group A: Transcatheter Aortic Valve Replacement1 intervention
Group B: Transcatheter Edge-to-Edge Repair1 intervention
Group C: Transcatheter Tricuspid Valve Annuloplasty1 intervention
Group D: Device: Surgical Aortic Valve Replacement1 intervention

Trial outcomes

Primary outcomes

1

Mortality

Time frame
Up to 1 year post-procedure
2

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
3

Hospitalization

Time frame
Up to 1 year post-procedure
4

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

Secondary outcomes

1

Other procedural or valve-related complications

Time frame
Periprocedural
2

New conduction disturbances and arrhythmias

Time frame
Up to 1 year post-procedure
3

Acute kidney injury

Time frame
Periprocedural
4

Myocardial infarction

Time frame
Up to 1 year post-procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Anzhen Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: