Diseases of Mitral and Aortic ValvesNCT02755220
Cingularbio® Heart Valve Clincial Study
A study testing Cingularbio® Aortic valve replacement in people with Diseases of Mitral and Aortic Valves, run by Shanghai Cingularbio Co. Ltd at 5 sites in 3 countries.
Trial summary
This study aimed to evaluate the safety and effectiveness of Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement in Chinese population Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Diseases of Mitral and Aortic Valves
- What is being tested?
- Cingularbio® Aortic valve replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Jan 2016to Apr 2019
- Phase
- Interventional
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
The inclusion criteria were as follows: 1) patient who had heart valve disease requiring a surgical replacement as indicated in the preoperative evaluation; 2) patient aged between 60-85 years; 3) patient whose preoperative heart function less than NYHA functional class IV; 4) patient who signed the informed consent before surgery; 5) patient who agrees to finish the follow-up. The exclusion criteria were as follows: 1) patient with prior valve replacement; 2) patient who requires concomitant tricuspid or pulmonary valve replacement; 3) patient who requires concomitant coronary artery bypass graft surgery; 4) patient with active infective endocarditis or drug abuse; 5) patient whose life time expectancy less than 12 months; 6) patient who was unable to follow anticoagulation treatment.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Poland3 sites
Klinika Kardiochirurgii
Katowice
Klinika Kardiochirurgii
Krakow
Klinika Kardiochirurgii
Warsaw
China1 site
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Prospective, Mutli-center, Open Lable, Single Arm Study to Evaluate the Safety and Effectiveness of Cingularbio® Heart Valve in Aortic/Mitral Valve Replacement Patients
This study aimed to evaluate the safety and effectiveness of Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement in Chinese population
Read the detailed description
single arm, 12 month follow up, mutile center, to assess the safety and effectiveness of Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement patients
- Conditions
- Diseases of Mitral and Aortic Valves
- Being tested
- Cingularbio® Aortic valve replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cingularbio® Aortic valve replacementDevice
the patients will be replaced by Cingularbio heart valve
| Study group | Role | What they receive |
|---|---|---|
| Cingularbio® Heart valve | Experimental | the patients will replaced by artificial heart valve Receives: Device: Cingularbio® Aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
device related adverse valve events
device related events including Thromboembolism, Valve thrombosis,Major hemorrhage, Major paravalvular leak
Measured: 12 month
Secondary outcomes (9)
rate of procedural success
device implant success
Measured: post-operative
the difference between baseline and 1 year in Effective orifice area (EOA)
the difference between baseline and 1 year in Effective orifice area (EOA) in echocardiographic hemodynamic
Measured: 1year
the difference between baseline and 1 year in pressure gradient (PG)
the difference between baseline and 1 year in pressure gradient (PG) in echocardiographic hemodynamic
Measured: 1year
the difference between baseline and 1 year in Peak aortic valve velocity
the difference between baseline and 1 year in Peak aortic valve velocity in echocardiographic hemodynamic
Measured: 1year
improvement in NYHA functional class
the NYHA score between baseline and 1 year
Measured: 1year
mortality
the mortality rate at 1 year
Measured: 1 year
structural valve deterioration
the SVD rate at 1 year
Measured: 1 year
reoperation
the reoperation rate at 1 year
Measured: 1 year
valve-related adverse events
all valve related AEs (not primary endpoint events) at 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diseases of Mitral and Aortic ValvesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Cingularbio Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- chunsheng wang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755220
- Sponsor's protocol ID
- XZBM-2015-01
- Status last verified
- Apr 2020
- First submitted
- 24 Apr 2016
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: the publication will be started after study close out
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Mutli-center, Open Lable, Single Arm Study to Evaluate the Safety and Effectiveness of Cingularbio® Heart Valve in Aortic/Mitral Valve Replacement Patients
- ClinicalTrials.gov ID
- NCT02755220
- Acronym / sponsor ID
- XZBM-2015-01
- Conditions
- Diseases of Mitral and Aortic Valves
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Shanghai Cingularbio Co. LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 28 Apr 2016 (estimated)
- 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.
This study aimed to evaluate the safety and effectiveness of Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement in Chinese population
Detailed description
single arm, 12 month follow up, mutile center, to assess the safety and effectiveness of Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cingularbio® Heart valve | Experimental | Device: Cingularbio® Aortic valve replacementthe patients will replaced by artificial heart valve |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Cingularbio® Aortic valve replacementthe patients will be replaced by Cingularbio heart valve | Device | Cingularbio® Heart valve |
Primary outcome
device related adverse valve events
Time frame: 12 month
device related events including Thromboembolism, Valve thrombosis,Major hemorrhage, Major paravalvular leak
9 secondary outcomes
rate of procedural success
Time frame: post-operative
the difference between baseline and 1 year in Effective orifice area (EOA)
Time frame: 1year
the difference between baseline and 1 year in pressure gradient (PG)
Time frame: 1year
the difference between baseline and 1 year in Peak aortic valve velocity
Time frame: 1year
improvement in NYHA functional class
Time frame: 1year
mortality
Time frame: 1 year
structural valve deterioration
Time frame: 1 year
reoperation
Time frame: 1 year
valve-related adverse events
Time frame: 1 year
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 28 Apr 2022.
- Individual participant dataSharing planned: No. the publication will be started after study close out
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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.
chunsheng wang principal investigator
Fudan University
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cingularbio® Aortic valve replacement in people with Diseases of Mitral and Aortic Valves, run by Shanghai Cingularbio Co. Ltd at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland, Belgium, 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?
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?
device related adverse valve events (time frame: 12 month). 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 28 Apr 2022.