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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Stenosis; Mitral Regurgitation; Aortic Regurgitation; Tricuspid Regurgitation
• Intervention / Treatment: Device: Transcatheter Aortic Valve Replacement; Device: Transcatheter Edge-to-Edge Repair; Device: Transcatheter Tricuspid Valve Annuloplasty; Device: Surgical Aortic Valve Replacement

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.

• Study Type: Observational
• Enrollment (Estimated): 5500

Contacts and Locations

• Study Contact: Name: Guangyuan Song, MD, PhD; Phone Number: +86 13801120805; Email: songgy_anzhen@vip.163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Beijing Anzhen Hospital
      • Contact: Guangyuan Song, MD, PhD; Phone Number: +86 13801120805; Email: songgy_anzhen@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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
Device: Surgical Aortic Valve Replacement	Device: Surgical Aortic Valve Replacement; Surgical Aortic Valve Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Freedom from mortality.; Successful access, delivery of the device, and retrieval of the delivery system.; Correct positioning of a single prosthetic heart valve into the proper anatomical location.; 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: Technical success; Freedom from mortality; Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication; 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: Freedom from all-cause mortality; Freedom from all stroke; Freedom from VARC type 2-4 bleeding; Freedom from major vascular, access-related, or cardiac structural complication; Freedom from acute kidney injury stage 3 or 4; Freedom from moderate or severe aortic regurgitation; Freedom from new permanent pacemaker due to procedure-related conduction abnormalities; 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: Freedom from all-cause mortality; Freedom from all stroke; Freedom from hospitalization for procedure- or valve-related causes; Freedom from KCCQ Overall Summary Score <45 or decline from baseline of >10 point	Up to 1 year post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Class I, II, III, or IV	Up to 1 year post-procedure
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

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 10, 2026
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: April 20, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Tricuspid Valve Insufficiency; Mitral Valve Insufficiency; Aortic Valve Insufficiency; Surgical Procedures, Operative; Cardiovascular Surgical Procedures; Cardiac Surgical Procedures; Thoracic Surgical Procedures; Prosthesis Implantation; Heart Valve Prosthesis Implantation; Transcatheter Aortic Valve Replacement
• Other Study ID Numbers: Beijinganzhen20260406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes