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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: An Active Post-Market Surveillance Study Assessing the Real-World Clinical Applicability, Long-Term Safety, and Effectiveness of Innovative Medical Devices for Valvular Heart Disease

Conditions

Aortic Stenosis, Aortic Regurgitation, Mitral Regurgitation, Tricuspid Regurgitation

Being tested

Transcatheter Aortic Valve Replacement, Transcatheter Edge-to-Edge Repair, Transcatheter Tricuspid Valve Annuloplasty, Surgical Aortic Valve Replacement

Medical subject headings

Aortic Valve Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency, Tricuspid Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Transcatheter Aortic Valve ReplacementDevice

  Transcatheter Aortic Valve Replacement

• Transcatheter Edge-to-Edge RepairDevice

  Transcatheter Edge-to-Edge Repair

• Transcatheter Tricuspid Valve AnnuloplastyDevice

  Transcatheter Tricuspid Valve Annuloplasty

• Surgical Aortic Valve ReplacementDevice

  Surgical Aortic Valve Replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Mortality

   Measured: 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.

   Measured: Up to 1 year post-procedure

3. Hospitalization

   Measured: 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.

   Measured: Up to 1 year post-procedure

5. Vascular and access-related complications

   Measured: Periprocedural

6. Cardiac structural complications

   Measured: Periprocedural

7. Bioprosthetic valve dysfunction

   Measured: Up to 1 year post-procedure

8. Clinically significant valve thrombosis

   Measured: Up to 1 year post-procedure

9. 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.

   Measured: Periprocedural

10. 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

    Measured: at 30 days

11. 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

    Measured: at 30 days

12. 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

    Measured: Up to 1 year post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted26 May 2026
2. Study start10 May 2026 (estimated)
3. Primary completion31 Jan 2029 (estimated)
4. Study completion31 Jan 2029 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Aortic StenosisStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.