Active Post-Market Surveillance of Innovative Devices for Valvular Heart Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
None
Trial design
Treatments tested in this trial
- Transcatheter Aortic Valve Replacement
- Transcatheter Edge-to-Edge Repair
- Transcatheter Tricuspid Valve Annuloplasty
- Surgical Aortic Valve Replacement
Treatment groups
5,500 Participants
are divided into 4 treatment groupsLocations
1Beijing Anzhen Hospital100029, BeijingBeijing Municipality, China
Sponsors and collaborators
Beijing Anzhen Hospital
Lead sponsor
Source ClinicalTrials.gov