Aortic Valve ReplacementINSPIRIS ChinaNCT05404880
INSPIRIS China PMCF Study
An observational study of Aortic Valve Replacement, run by Edwards Lifesciences at 12 sites in China.
Trial summary
The objective of this post-market trial is to evaluate long term safety and performance of the Edwards Lifesciences INSPIRIS RESILIA aortic valve in Chinese patients in a real-world clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Replacement
- What is being tested?
- EDWARDS INSPIRIS RESILIA Aortic Valve
- Type of treatment
- Medical device
- How many people
- 255 participants
- Where
- 12 sitesChina
- Study dates
- 13 Jul 2022to Dec 2034
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects requiring an elective replacement of their native or prosthetic aortic valve who have agreed to participate in the study.
Who may be able to join
- Subject is 18 years or older
- Subjects requiring an elective replacement of their native or prosthetic aortic valve as indicated per the IFU
- Subject is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery, with or without ascending aorta replacement
- Provide signed informed consent prior to the study participation
Who cannot join
- Valve implantation is contraindicated per the IFU
- Requires planned multiple valve replacement/ repair
- Has active endocarditis/myocarditis prior to the scheduled aortic replacement surgery
- Estimated Life expectancy< 12 months
- Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Fuwai Hospital, CAMS & PUMC
Beijing, Beijing Municipality, 100037
Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Fuwai Yunnan Cardiovascular Hospital
Kunming, Yunnan, 650102
Nanjing First Hospital
Nanjing, Jiangsu, 210012
Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
Shenzhen, Guangdong, 518038
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710065
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, 361008
Henan Provincial Chest Hospital
Zhengzhou, Henan, 450008
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, 451460
About this study
Official title: Post-Market Clinical Follow-up Study of Edwards Lifesciences INSPIRIS RESILIA Aortic Valve in Chinese Population
The objective of this post-market trial is to evaluate long term safety and performance of the Edwards Lifesciences INSPIRIS RESILIA aortic valve in Chinese patients in a real-world clinical setting.
Read the detailed description
The trial is a multi-center, prospective, single-arm study that will implant up to 250 subjects with the Edwards INSPIRIS RESILIA aortic valve and will continue to follow and assess them after implant for 5 years. In an effort to obtain sufficient long-term data, all subjects will be asked to reconsent to extended follow-up through 10 years.
- Conditions
- Aortic Valve Replacement
- Being tested
- EDWARDS INSPIRIS RESILIA Aortic Valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDWARDS INSPIRIS RESILIA Aortic ValveDevice
Surgical replacement of the aortic valve with the INSPIRIS RESILIA Aortic Valve.
| Study group | Role | What they receive |
|---|---|---|
| EDWARDS INSPIRIS RESILIA Aortic Valve | Subjects who were treated with the INSPIRIS RESILIA aortic heart valve. Receives: Device: EDWARDS INSPIRIS RESILIA Aortic Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject's Occurrence Rate of Study Valve Related Death
The primary safety endpoint is the percentage of study valve related death which includes death caused by structural valve deterioration, nonstructural dysfunction, valve thrombosis, embolism, bleeding event, or operated valve endocarditis; death related to reintervention on the operated valve; or sudden, unexplained death.
Measured: 10 Years
Subject's Occurrence Rate of Structural Valve Deterioration
The primary safety endpoint is the percentage of Structural Valve Deterioration which includes dysfunction or deterioration involving the operated valve (exclusive of infection or thrombosis), as determined by re-operation, autopsy, or clinical investigation.
Measured: 10 Years
Subject's Occurrence Rate of Re-operation on the Study Valve
The primary safety endpoint is the reoperation rate on the study valve which is any operation that repairs, alters, or replaces the study valve, which occurs after the completion of the procedure and the transfer out of the procedure room.
Measured: 10 Years
Subject's Occurrence Rate of Major Bleeding
The primary safety endpoint is the rate of major bleeding which is any episode of major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. Vision loss) or necessitates transfusion of 3 or more units of PRBC, pericardiocentesis, or exploration/reoperation for bleeding.
Measured: 10 Years
Subject's Occurrence Rate of Thromboembolic Events
The primary safety endpoint is the rate of thromboembolic events which is an embolic event that occurs in absence of infection (endocarditis) starting from anesthesia time. Embolism may be manifested by a neurologic event (Stroke or Transient Ischemic Attack) or a non-cerebral embolic event.
Measured: 10 Years
Subject's Occurrence Rate of Stroke
The primary safety endpoint is the rate of strokes which is a prolonged (>72 hours) or permanent neurologic deficit that is usually associated with abnormal results of magnetic resonance imaging or computed tomographic scans.
Measured: 10 Years
Subject's Occurrence Rate of Transient Ischemic Attack
The primary safety endpoint is the rate of transient ischemic attacks which is characterized by fully reversible symptoms of short duration.
Measured: 10 Years
Subject's Occurrence Rate of Non-Cerebral Thromboembolism
The primary safety endpoint is the rate of non-cerebral thromboembolism which is an embolus documented operatively, at autopsy, or clinically that produces signs or symptoms attributable to complete or partial obstruction of a peripheral artery (does not include deep vein thrombosis).
Measured: 10 Years
Secondary outcomes (6)
Subject's Average Mean Gradient at 10 Years
Hemodynamic performance - Mean gradients as evaluated by echocardiography
Measured: 10 Years
Subject's Average Peak Gradient at 10 Years
Hemodynamic performance - Peak gradients as evaluated by echocardiography
Measured: 10 Years
Subject's Average Effective Orifice Area at 10 Years
Hemodynamic performance - Effective Orifice Area evaluated by echocardiography
Measured: 10 Years
Subject's Average Effective Orifice Area Index at 10 Years
Hemodynamic performance - Effective Orifice Area Index evaluated by echocardiography
Measured: 10 Years
Amount of Aortic Central Regurgitation in Subjects at 10 Years
Hemodynamic performance - Aortic central regurgitation evaluated by echocardiography
Measured: 10 Years
Amount of Aortic Paravalvular Regurgitation in Subjects at 10 Years
Hemodynamic performance - Aortic paravalvular regurgitation evaluated by echocardiography
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start13 Jul 2022
- Primary completionMar 2034 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve ReplacementStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe 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
- 255 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd., Rundo International Pharmaceutical Research & Development Co.,Ltd., Chinese Academy of Medical Sciences, Fuwai Hospital
- Responsible party
- Sponsor
- Investigators
- Hansong Sun, Professor, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404880
- Sponsor's protocol ID
- 2021-09
- Acronym
- INSPIRIS China
- Status last verified
- Sep 2026
- First submitted
- 31 May 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-up Study of Edwards Lifesciences INSPIRIS RESILIA Aortic Valve in Chinese Population
- ClinicalTrials.gov ID
- NCT05404880
- Acronym / sponsor ID
- INSPIRIS China / 2021-09
- Conditions
- Aortic Valve Replacement
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Collaborators
- Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd., Rundo International Pharmaceutical Research & Development Co.,Ltd., Chinese Academy of Medical Sciences, Fuwai Hospital
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- Mar 2034 (estimated)
- Study completion
- Dec 2034 (estimated)
- First posted
- 3 Jun 2022 (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 objective of this post-market trial is to evaluate long term safety and performance of the Edwards Lifesciences INSPIRIS RESILIA aortic valve in Chinese patients in a real-world clinical setting.
Detailed description
The trial is a multi-center, prospective, single-arm study that will implant up to 250 subjects with the Edwards INSPIRIS RESILIA aortic valve and will continue to follow and assess them after implant for 5 years. In an effort to obtain sufficient long-term data, all subjects will be asked to reconsent to extended follow-up through 10 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EDWARDS INSPIRIS RESILIA Aortic Valve | – | Device: EDWARDS INSPIRIS RESILIA Aortic ValveSubjects who were treated with the INSPIRIS RESILIA aortic heart valve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects requiring an elective replacement of their native or prosthetic aortic valve who have agreed to participate in the study.
Key inclusion criteria (4 listed)
- Subject is 18 years or older
- Subjects requiring an elective replacement of their native or prosthetic aortic valve as indicated per the IFU
- Subject is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery, with or without ascending aorta replacement
- Provide signed informed consent prior to the study participation
Key exclusion criteria (5 listed)
- Valve implantation is contraindicated per the IFU
- Requires planned multiple valve replacement/ repair
- Has active endocarditis/myocarditis prior to the scheduled aortic replacement surgery
- Estimated Life expectancy< 12 months
- Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDWARDS INSPIRIS RESILIA Aortic ValveSurgical replacement of the aortic valve with the INSPIRIS RESILIA Aortic Valve. | Device | EDWARDS INSPIRIS RESILIA Aortic Valve |
Primary outcome
Subject's Occurrence Rate of Study Valve Related Death
Time frame: 10 Years
The primary safety endpoint is the percentage of study valve related death which includes death caused by structural valve deterioration, nonstructural dysfunction, valve thrombosis, embolism, bleeding event, or operated valve endocarditis; death related to reintervention on the operated valve; or sudden, unexplained death.
Subject's Occurrence Rate of Structural Valve Deterioration
Time frame: 10 Years
The primary safety endpoint is the percentage of Structural Valve Deterioration which includes dysfunction or deterioration involving the operated valve (exclusive of infection or thrombosis), as determined by re-operation, autopsy, or clinical investigation.
Subject's Occurrence Rate of Re-operation on the Study Valve
Time frame: 10 Years
The primary safety endpoint is the reoperation rate on the study valve which is any operation that repairs, alters, or replaces the study valve, which occurs after the completion of the procedure and the transfer out of the procedure room.
Subject's Occurrence Rate of Major Bleeding
Time frame: 10 Years
The primary safety endpoint is the rate of major bleeding which is any episode of major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. Vision loss) or necessitates transfusion of 3 or more units of PRBC, pericardiocentesis, or exploration/reoperation for bleeding.
Subject's Occurrence Rate of Thromboembolic Events
Time frame: 10 Years
The primary safety endpoint is the rate of thromboembolic events which is an embolic event that occurs in absence of infection (endocarditis) starting from anesthesia time. Embolism may be manifested by a neurologic event (Stroke or Transient Ischemic Attack) or a non-cerebral embolic event.
Subject's Occurrence Rate of Stroke
Time frame: 10 Years
The primary safety endpoint is the rate of strokes which is a prolonged (>72 hours) or permanent neurologic deficit that is usually associated with abnormal results of magnetic resonance imaging or computed tomographic scans.
Subject's Occurrence Rate of Transient Ischemic Attack
Time frame: 10 Years
The primary safety endpoint is the rate of transient ischemic attacks which is characterized by fully reversible symptoms of short duration.
Subject's Occurrence Rate of Non-Cerebral Thromboembolism
Time frame: 10 Years
The primary safety endpoint is the rate of non-cerebral thromboembolism which is an embolus documented operatively, at autopsy, or clinically that produces signs or symptoms attributable to complete or partial obstruction of a peripheral artery (does not include deep vein thrombosis).
6 secondary outcomes
Subject's Average Mean Gradient at 10 Years
Time frame: 10 Years
Subject's Average Peak Gradient at 10 Years
Time frame: 10 Years
Subject's Average Effective Orifice Area at 10 Years
Time frame: 10 Years
Subject's Average Effective Orifice Area Index at 10 Years
Time frame: 10 Years
Amount of Aortic Central Regurgitation in Subjects at 10 Years
Time frame: 10 Years
Amount of Aortic Paravalvular Regurgitation in Subjects at 10 Years
Time frame: 10 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.
Related trials for Aortic Valve Replacement
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement, Transcatheter Heart Valve Thrombosis
Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
Aortic Valve Stenosis, Hypertrophy, Left Ventricular
Active, not recruiting
The JenaValve ALIGN-AR LVAD Registry
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Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
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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.
Hansong Sun, Professor principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Replacement, run by Edwards Lifesciences at 12 sites in China.
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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Subject's Occurrence Rate of Study Valve Related Death (time frame: 10 Years). The study lists 8 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 2 Oct 2026.