An observational study in AORTIC VALVE DISEASES and Mitral Valve Disease, sponsored by West China Hospital. Completed. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by West China Hospital · Observational
The goal of this prospective cohort study is to evaluate the long term clinical performance of the Kingstron X LINK bioprosthesis for aortic or mitral valve replacement, and verify whether its postoperative outcomes are non inferior to commercially available Medtronic Mosaic and Edwards Perimount Magna bioprostheses. It will also assess safety, hemodynamic performance and patient quality of life after valve implantation. The main questions it aims to answer are: Does the Kingstron X LINK bioprosthesis yield non inferior long term overall survival compared with Medtronic and Edwards bioprostheses? What are the differences in structural valve degeneration, adverse events, reoperation free survival and hemodynamic outcomes between the Kingstron X LINK and the comparator bioprostheses? How does patient quality of life differ across the three bioprosthesis groups during long term follow up? Researchers will compare patients receiving Kingstron X LINK bioprostheses against those receiving Medtronic Mosaic or Edwards Perimount Magna bioprostheses, all of whom underwent surgical aortic and/or mitral valve replacement at West China Hospital.
Participants will: Receive surgical aortic valve replacement and/or mitral valve replacement with one of the three types of bioprosthetic valves. Complete annual clinical follow up including clinical examination, hemodynamic assessment and quality of life evaluation. Be monitored for adverse events, structural valve degeneration and reoperation events over long term follow up.
234 studies on the registry are indexed under Aortic Valve Disease; 70 are open to participants now.
This study's enrollment of 268 is above the median of 200 across 106 observational studies indexed under Aortic Valve Disease.
Browse Aortic Valve Disease studies →West China Hospital is the lead sponsor of 501 studies on the registry; 246 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients receiving surgical aortic or mitral bioprosthetic valve replacement (Kingstron X-LINK, Medtronic or Edwards) at West China Hospital. Participants will be followed annually for up to 5 years after valve implantation for clinical, echocardiographic and safety assessments.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- (1) Adults scheduled to undergo or undergoing primary surgical AVR with either a Kingstron X-LINK, Medtronic Mosaic, or Edwards Perimount Magna bioprosthesis between November 2015 and August 2018.
(2) Adults scheduled to undergo or undergoing primary surgical MVR with a Kingstron X-LINK, Medtronic Mosaic, or Edwards Perimount Magna bioprosthesis during the same interval.
Exclusion Criteria:
(1) Patients with active or suspected infective endocarditis at the time of valve surgery were excluded.
(2) Patients who had previously undergone cardiac valve replacement surgery were excluded.
(3) Patients who declined or were unable to provide written for study participation and annual follow-up were excluded.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who received the Kingstron X-LINK bioprosthesis were assigned to the Kingstron group
Patients who received Medtronic Mosaic or Edwards Perimount Magna bioprostheses were assigned to the control group
All-cause mortality at 5 years
All-cause mortality defined as death from any cause, compared among patients receiving Kingstron X-LINK, Medtronic and Edwards bioprostheses
Time frame: 5 years after valve implantation
Freedom from severe structural valve degeneration (SVD) at 5 years
Freedom from stage 3 structural valve degeneration (SVD) defined by VARC-3 criteria, compared across the three bioprosthesis groups
Time frame: 5 years after valve implantation
Reoperation-free survival at 5 years
Freedom from reoperation for valve-related dysfunction, including surgical or transcatheter reintervention
Time frame: 5 years after valve implantation
Valve-related adverse events
Composite of valve thrombosis, thromboembolic stroke, bleeding events, endocarditis, and non-structural valve deterioration
Time frame: Up to 5 years after valve implantation
Echocardiographic hemodynamic performance
Mean transvalvular gradient and effective orifice area measured by transthoracic echocardiography
Time frame: 1, 2, 3, 4 and 5 years after implantation
Health-related quality of life
Patient quality of life assessed by validated questionnaires
Time frame: 5 years after implantation
No study locations are listed for this record.
Ran from Nov 2015 to primary completion in Dec 2023, 97 months.
Of 47 non-industry observational studies under Aortic Valve Disease, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 147. This study's 97 months is above that.
Counting every sponsor, half of 56 studies reached it within 49 months; a quarter within 23 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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