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

NCT07605624 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: Beijinganzhen20260406
• Study Type: observational
• Target: 5,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis; Aortic Regurgitation; Mitral Regurgitation; Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (12)

• Mortality

  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.

  Up to 1 year post-procedure

• Hospitalization

  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.

  Up to 1 year post-procedure

• 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

  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.

  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

  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

  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

  Up to 1 year post-procedure

Secondary Outcomes (9)

• 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

Study Arms (4)

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

Device: Surgical Aortic Valve Replacement

Device: Surgical Aortic Valve Replacement

Interventions

Transcatheter Aortic Valve Replacement DEVICE

Transcatheter Aortic Valve Replacement

Transcatheter Aortic Valve Replacement

Transcatheter Edge-to-Edge Repair DEVICE

Transcatheter Edge-to-Edge Repair

Transcatheter Edge-to-Edge Repair

Transcatheter Tricuspid Valve Annuloplasty DEVICE

Transcatheter Tricuspid Valve Annuloplasty

Transcatheter Tricuspid Valve Annuloplasty

Surgical Aortic Valve Replacement DEVICE

Surgical Aortic Valve Replacement

Device: Surgical Aortic Valve Replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency; Mitral Valve Insufficiency; Tricuspid Valve Insufficiency

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Central Study Contacts

Guangyuan Song, MD, PhD

CONTACT

+86 13801120805; songgy_anzhen@vip.163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 26, 2026
• Study Start: May 10, 2026
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)