Active Post-Market Surveillance of Innovative Devices for Valvular Heart Disease
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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
Trial design
5,500 participants in 4 patient groups
Trial contacts and locations
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Central trial contact
Guangyuan Song, MD, PhD
Data sourced from clinicaltrials.gov
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