Aortic Valve DiseaseNCT05391191
Safety and Feasibility of TRISKELE in Severe AS
A study testing MitrAssist TRISKELE® transcatheter aortic valve system in people with Aortic Valve Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This clinical study is a prospective、single arm and exploratory study, to explore the feasibility and safety of MitrAssist TRISKELE® transcatheter aortic valve system in the treatment of patients with severe aortic stenosis. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- MitrAssist TRISKELE® transcatheter aortic valve system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2022to 31 Mar 2023
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 70 years old;
- Patients with symptomatic severe aortic stenosis (echocardiographic mean pressure gradient across aortic valve ≥ 40mmhg, or blood flow velocity across aortic valve ≥ 4.0m/s, or aortic valve area < 0.8cm2, or effective aortic valve area index < 0.5cm2/m2);
- Patients with biological valve decay meeting the criteria in (2) above;
- NYHA grade ≥ grade II;
- The life expectancy after artificial valve implantation is more than 1 year;
- Patients who are anatomically suitable for transcatheter aortic valve implantation;
- Two or more cardiothoracic surgeons evaluate and record it as surgical contraindication or as high-risk surgery and unsuitable for routine surgery;
- Patients who can understand the purpose of the trial, voluntarily participate in and sign informed consent, and are willing to accept relevant examination and clinical follow-up.
Who cannot join
- Acute myocardial infarction occurred within 30 days before this treatment (WHO definition: Q-wave MI, or non-Q-wave MI with elevated creatine kinase isoenzyme and troponin T);
- Patients whose aortic root anatomy and lesions are not suitable for artificial valve implantation;
- Compound aortic valve disease (aortic stenosis with severe regurgitation); Severe mitral regurgitation;
- Hematological malignancies, hemophilia and other coagulation disorders;
- Hemodynamic instability, requiring mechanical cardiac assistance;
- Emergency operation for any reason;
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- Obstructive hypertrophic cardiomyopathy;
- Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) < 30%;
- Severe right ventricular dysfunction;
- Echocardiography showed the presence of intracardiac mass, thrombus or vegetations;
- Active peptic ulcer or upper gastrointestinal hemorrhage within 3 months;
- Allergic to nickel titanium alloy, stainless steel alloy, PU (polyurethane), or contrast agent; Unable to tolerate anticoagulant and antiplatelet therapy;
- Cerebrovascular events (CVA) occurred within 3 months, including ischemic stroke and hemorrhagic stroke, excluding transient ischemic attack (TIA);
- Vascular diseases affecting the instrument approach;
- Infective endocarditis in active phase or other active infections;
- Those who have participated in clinical trials of other drugs or medical devices before enrollment and have not reached the time limit of the main research endpoint.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hopital of Fudan University
Shanghai, Shanghai Municipality, 200032
XIAOCHUN ZHANG, MD
About this study
Official title: Prospective Clinical Study on the Safety and Clinical Feasibility of Exploring TRISKELE® Transcatheter Aortic Valve System in the Treatment of Severe Aortic Stenosis
This clinical study is a prospective、single arm and exploratory study, to explore the feasibility and safety of MitrAssist TRISKELE® transcatheter aortic valve system in the treatment of patients with severe aortic stenosis.
Read the detailed description
This study was a prospective、single arm clinical trial design. For patients with surgical contraindications or high-risk symptomatic severe aortic stenosis, MitrAssist TRISKELE® transcatheter aortic valve system was performed by aortic valve replacement. Patients were followed up 30 days (± 7 days) after operation for the feasibility and safety analysis to explore the test device in patients with surgical contraindications or high-risk symptomatic severe aortic stenosis.In this study, a clinical trial institution meeting the national qualification is planned to be selected as the clinical research center, and 7 patients are planned to be selected.
The success rate of operation 30 days after operation was taken as the main evaluation index and the success of device implantation, the result of echocardiography evaluation of valve function, the improvement rate of NYHA cardiac function classification, six minute walking distance and the score of Kansas City Cardiomyopathy Questionnaire were taken as the secondary evaluation indexes, to evaluate clinical effectiveness of TRISKELE® transcatheter aortic valve system; Adverse events, serious adverse events, major cardiovascular and cerebrovascular adverse events, device defects, vital signs and laboratory examination results were used as safety indicators to evaluate the safety of the test device .
- Conditions
- Aortic Valve Disease
- Being tested
- MitrAssist TRISKELE® transcatheter aortic valve system
- 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.
MitrAssist TRISKELE® transcatheter aortic valve systemDevice
Patients were treated with MitrAssist TRISKELE® transcatheter aortic valve system
| Study group | Role | What they receive |
|---|---|---|
| MitrAssist TRISKELE® transcatheter aortic valve system | Experimental | Device: MitrAssist TRISKELE® transcatheter aortic valve system Receives: Device: MitrAssist TRISKELE® transcatheter aortic valve system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Freedom from mortality; Successful access, delivery of the device, and retrieval of the delivery System; Correct positioning of a single prosthetic heart valve into the proper anatomical location; Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication
Measured: at exit from procedure room
Device success
Technical success; Freedom from mortality; Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication; Intended performance of the valve (mean gradient <20 mmHg, peak velocity<3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation)
Measured: within 30 days after operation
Secondary outcomes (3)
Early safety endpoint
Freedom from all-cause mortality; Freedom from all stroke; Freedom from VARC type 2-4 bleeding (in trials where control group is surgery, it is appropriate to include only Type 3 and 4 bleeding); Freedom from major vascular, access-related, or cardiac structural complication; Freedom from acute kidney injury stage 3 or 4; Freedom from moderate or severe aortic regurgitation; Freedom from new permanent pacemaker due to procedure-related conduction abnormalities; Freedom from surgery or intervention related to the device
Measured: within 30 days after operation
six minute walk distance (6MWD) test
The six minute walk distance (6MWD) test (see Appendix II) was used to record the patients' six minute walk distance before operation and 30 days after operation. The six minute walk test is mainly used to evaluate the efficacy of treatment intervention in patients with moderate and severe cardiovascular diseases, and can objectively reflect the actual daily activity ability
Measured: within 30 days after operation
The quality of life improved 30 days after operation
SF-12 quality of life table was used to score the cardiac function improvement before discharge and 30 days after operation. NYHA classification scheme was adopted for the classification of cardiac function.
Measured: within 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start6 Jul 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JUNBO GE, PHD, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391191
- Sponsor's protocol ID
- TRISKELE
- Status last verified
- Jul 2022
- First submitted
- 22 May 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study on the Safety and Clinical Feasibility of Exploring TRISKELE® Transcatheter Aortic Valve System in the Treatment of Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT05391191
- Acronym / sponsor ID
- TRISKELE
- Conditions
- Aortic Valve Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 25 May 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.
This clinical study is a prospective、single arm and exploratory study, to explore the feasibility and safety of MitrAssist TRISKELE® transcatheter aortic valve system in the treatment of patients with severe aortic stenosis.
Detailed description
This study was a prospective、single arm clinical trial design. For patients with surgical contraindications or high-risk symptomatic severe aortic stenosis, MitrAssist TRISKELE® transcatheter aortic valve system was performed by aortic valve replacement. Patients were followed up 30 days (± 7 days) after operation for the feasibility and safety analysis to explore the test device in patients with surgical contraindications or high-risk symptomatic severe aortic stenosis.In this study, a clinical trial institution meeting the national qualification is planned to be selected as the clinical research center, and 7 patients are planned to be selected.
The success rate of operation 30 days after operation was taken as the main evaluation index and the success of device implantation, the result of echocardiography evaluation of valve function, the improvement rate of NYHA cardiac function classification, six minute walking distance and the score of Kansas City Cardiomyopathy Questionnaire were taken as the secondary evaluation indexes, to evaluate clinical effectiveness of TRISKELE® transcatheter aortic valve system; Adverse events, serious adverse events, major cardiovascular and cerebrovascular adverse events, device defects, vital signs and laboratory examination results were used as safety indicators to evaluate the safety of the test device .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MitrAssist TRISKELE® transcatheter aortic valve system | Experimental | Device: MitrAssist TRISKELE® transcatheter aortic valve systemDevice: MitrAssist TRISKELE® transcatheter aortic valve system |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Age ≥ 70 years old;
- Patients with symptomatic severe aortic stenosis (echocardiographic mean pressure gradient across aortic valve ≥ 40mmhg, or blood flow velocity across aortic valve ≥ 4.0m/s, or aortic valve area < 0.8cm2, or effective aortic valve area index < 0.5cm2/m2);
- Patients with biological valve decay meeting the criteria in (2) above;
- NYHA grade ≥ grade II;
- The life expectancy after artificial valve implantation is more than 1 year;
Key exclusion criteria (16 listed)
- Acute myocardial infarction occurred within 30 days before this treatment (WHO definition: Q-wave MI, or non-Q-wave MI with elevated creatine kinase isoenzyme and troponin T);
- Patients whose aortic root anatomy and lesions are not suitable for artificial valve implantation;
- Compound aortic valve disease (aortic stenosis with severe regurgitation); Severe mitral regurgitation;
- Hematological malignancies, hemophilia and other coagulation disorders;
- Hemodynamic instability, requiring mechanical cardiac assistance;
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 |
|---|---|---|
| MitrAssist TRISKELE® transcatheter aortic valve systemPatients were treated with MitrAssist TRISKELE® transcatheter aortic valve system | Device | MitrAssist TRISKELE® transcatheter aortic valve system |
Primary outcome
Technical success
Time frame: at exit from procedure room
Freedom from mortality; Successful access, delivery of the device, and retrieval of the delivery System; Correct positioning of a single prosthetic heart valve into the proper anatomical location; Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication
Device success
Time frame: within 30 days after operation
Technical success; Freedom from mortality; Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication; Intended performance of the valve (mean gradient <20 mmHg, peak velocity<3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation)
3 secondary outcomes
Early safety endpoint
Time frame: within 30 days after operation
six minute walk distance (6MWD) test
Time frame: within 30 days after operation
The quality of life improved 30 days after operation
Time frame: within 30 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Individual participant dataSharing planned: No
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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.
JUNBO GE, PHD study chair
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MitrAssist TRISKELE® transcatheter aortic valve system in people with Aortic Valve Disease, run by Shanghai Zhongshan Hospital at 1 site 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 8 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact XIAOCHUN ZHANG, MD (8615002121366, zhang.xiaochun1@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: at exit from procedure room). 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 12 Jul 2022.