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Not yet recruiting NCT07605624

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

— Observational Aortic Stenosis Aortic Regurgitation Mitral Regurgitation Tricuspid Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcatheter Aortic Valve Replacement, Transcatheter Edge-to-Edge Repair, Transcatheter Tricuspid Valve Annuloplasty, Surgical Aortic Valve Replacement.
Who it may be relevant to
Registry conditions: Aortic Stenosis, Aortic Regurgitation, Mitral Regurgitation, Tricuspid Regurgitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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.

Interventions

  • Device Transcatheter Aortic Valve Replacement
    Transcatheter Aortic Valve Replacement
  • Device Transcatheter Edge-to-Edge Repair
    Transcatheter Edge-to-Edge Repair
  • Device Transcatheter Tricuspid Valve Annuloplasty
    Transcatheter Tricuspid Valve Annuloplasty
  • Device Surgical Aortic Valve Replacement
    Surgical Aortic Valve Replacement

Primary outcome measures

  • Mortality [Time frame: Up to 1 year post-procedure]
  • Rate of neurologic events [Time frame: Up to 1 year post-procedure]
  • Hospitalization [Time frame: Up to 1 year post-procedure]
  • Bleeding and transfusions [Time frame: Up to 1 year post-procedure]
  • Vascular and access-related complications [Time frame: Periprocedural]
  • Cardiac structural complications [Time frame: Periprocedural]
  • Bioprosthetic valve dysfunction [Time frame: Up to 1 year post-procedure]
  • Clinically significant valve thrombosis [Time frame: Up to 1 year post-procedure]
  • Technical success [Time frame: Periprocedural]
  • Device success [Time frame: at 30 days]
Secondary outcome measures (9)
  • Other procedural or valve-related complications [Time frame: Periprocedural]
  • New conduction disturbances and arrhythmias [Time frame: Up to 1 year post-procedure]
  • Acute kidney injury [Time frame: Periprocedural]
  • Myocardial infarction [Time frame: Up to 1 year post-procedure]
  • Leaflet thickening and reduced motion [Time frame: Up to 1 year post-procedure]
  • Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score [Time frame: Up to 1 year post-procedure]
  • New York Heart Association (NYHA) Functional Classification [Time frame: Up to 1 year post-procedure]
  • EuroQol 5-Dimension (EQ-5D) Questionnaire Score [Time frame: Up to 1 year post-procedure]
  • Change in 6-Minute Walk Distance (6MWD) [Time frame: Up to 1 year post-procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Anzhen Hospital — Beijing

Identifiers

NCT: NCT07605624 · Beijinganzhen20260406

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗