AORTIC VALVE DISEASESNCT07921797
Long-Term Performance of Kingstron X-LINK Compared With Commercial Bioprostheses
An observational study of AORTIC VALVE DISEASES and Mitral Valve Disease, run by West China Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- AORTIC VALVE DISEASES, Mitral Valve Disease
- How many people
- 268 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2015to 31 Dec 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- (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.
- 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.
Who cannot join
- (1) Patients with active or suspected infective endocarditis at the time of valve surgery were excluded.
- Patients who had previously undergone cardiac valve replacement surgery were excluded.
- Patients who declined or were unable to provide written informed consent for study participation and annual follow-up were excluded.
About this study
Official title: Long-term Outcomes of Kingstron X-LINK Bioprostheses Compared With Medtronic and Edwards Bioprostheses
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.
- Conditions
- AORTIC VALVE DISEASES, Mitral Valve Disease
- Keywords
- Kingstrobio X-LINK bioprosthetic valve, aortic valve replacement, mitral valve replacement, hemodynamic performance, long-term follow-up
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Kingstron group | Patients who received the Kingstron X-LINK bioprosthesis were assigned to the Kingstron group | |
| Control group | Patients who received Medtronic Mosaic or Edwards Perimount Magna bioprostheses were assigned to the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 5 years after valve implantation
Secondary outcomes (4)
Reoperation-free survival at 5 years
Freedom from reoperation for valve-related dysfunction, including surgical or transcatheter reintervention
Measured: 5 years after valve implantation
Valve-related adverse events
Composite of valve thrombosis, thromboembolic stroke, bleeding events, endocarditis, and non-structural valve deterioration
Measured: Up to 5 years after valve implantation
Echocardiographic hemodynamic performance
Mean transvalvular gradient and effective orifice area measured by transthoracic echocardiography
Measured: 1, 2, 3, 4 and 5 years after implantation
Health-related quality of life
Patient quality of life assessed by validated questionnaires
Measured: 5 years after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Nov 2015
- Primary completion31 Dec 2023
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AORTIC VALVE DISEASESStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 268 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- KingstronBio Medical Technology Co. Ltd., Suzhou, China
- Responsible party
- Principal investigator, Jiuhong Li, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921797
- Sponsor's protocol ID
- 2015(017)
- Other IDs
- HX-H1709108, 2024YFFK0138, 2024YFFK0358, 2026NSFSC1703, 2023HXBH052, 2024STI039
- Status last verified
- Oct 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Kingstron X-LINK Bioprostheses Compared With Medtronic and Edwards Bioprostheses
- ClinicalTrials.gov ID
- NCT07921797
- Acronym / sponsor ID
- 2015(017)
- Conditions
- AORTIC VALVE DISEASES, Mitral Valve Disease
- Keywords
- Kingstrobio X-LINK bioprosthetic valve, aortic valve replacement, mitral valve replacement, hemodynamic performance, long-term follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- KingstronBio Medical Technology Co. Ltd., Suzhou, China
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kingstron group | – | –Patients who received the Kingstron X-LINK bioprosthesis were assigned to the Kingstron group |
| Control group | – | –Patients who received Medtronic Mosaic or Edwards Perimount Magna bioprostheses were assigned to the control group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- (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.
- 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.
Key exclusion criteria (3 listed)
- (1) Patients with active or suspected infective endocarditis at the time of valve surgery were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality at 5 years
Time frame: 5 years after valve implantation
All-cause mortality defined as death from any cause, compared among patients receiving Kingstron X-LINK, Medtronic and Edwards bioprostheses
Freedom from severe structural valve degeneration (SVD) at 5 years
Time frame: 5 years after valve implantation
Freedom from stage 3 structural valve degeneration (SVD) defined by VARC-3 criteria, compared across the three bioprosthesis groups
4 secondary outcomes
Reoperation-free survival at 5 years
Time frame: 5 years after valve implantation
Valve-related adverse events
Time frame: Up to 5 years after valve implantation
Echocardiographic hemodynamic performance
Time frame: 1, 2, 3, 4 and 5 years after implantation
Health-related quality of life
Time frame: 5 years after implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of AORTIC VALVE DISEASES and Mitral Valve Disease, run by West China Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality at 5 years (time frame: 5 years after valve implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.