Aortic StenosisNCT05673525
A Clinical Trial of the Transcatheter Aortic Valve Implantation System With a Prospective, Multi-Center, One-Arm Approach to Evaluate the Efficacy and Safety in the Treatment of Patients With Severe Aortic Stenosis
A study testing Transcatheter Aortic Valve Implantation (KOKA-VALVE) in people with Aortic Stenosis, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
A Clinical Trial of the Transcatheter Aortic Valve Implantation System with a Prospective, Multi-Center, One-Arm Approach to Evaluate the Efficacy and Safety in the Treatment of Patients with Severe Aortic Stenosis Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Transcatheter Aortic Valve Implantation (KOKA-VALVE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2022to 30 Dec 2028
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Contraindication to surgery, or high risk for surgery (STS ≥ 8%) as assessed by the heart team; or other circumstances that make surgical valve replacement inappropriate.
- Age ≥65 years.
- Patients with symptomatic severe aortic stenosis (mean aortic transvalvular gradient by echocardiography ≥40 mmHg (1 mmHg=0.133 kPa), or transaortic flow velocity ≥4.0 m/s, or aortic valve orifice area <0.8 cm2, or effective aortic orifice area index <0.5 cm2 /m2).
- The subjects have been informed of the nature of this study, understand the purpose of the clinical trial, and voluntarily participate in and sign the informed consent form.
Who cannot join
- Life expectancy less than 1 year after implantation of the prosthetic valve.
- Patients had an acute heart attack within 1 month, or had a coronary stent or a pacing device implantation within 1 month, or had any therapeutic cardiac surgery within 1 month.
- Patients with aortic root anatomy and lesion that are not suitable for prosthetic valve implantation.
- Combined with severe insufficiency or stenosis of other valves and requiring surgical treatment.
- Hematologic cachexia, including leukopenia (WBC <3×10^9 /L), acute anemia (HB <90 g/L), thrombocytopenia (PLT <50 × 10^9 /L), bleeding constitution, and coagulation disorders.
- Untreated coronary artery disease requiring hematologic reconstruction.
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- Hypertrophic obstructive cardiomyopathy.
- Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%.
- Severe right ventricular insufficiency.
- The existent of intracardiac masses, thrombi or superfluous organisms by echocardiography.
- Patients who cannot tolerate anticoagulation or antiplatelet therapy.
- Patients had cerebrovascular event (CVA), including ischemic stroke and hemorrhagic stroke within 3 months.
- Decompensation of renal insufficiency.
- Active infective endocarditis or other active infection.
- Untreated conduction system disease requiring pacemaker implantation.
- Currently participating in an investigational drug or another device study that has not completed its primary endpoints or would clinically interfere with the endpoint of this study.
- Other circumstances that are assessed by the investigator to be unsuitable for interventional aortic valve therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Structral Heart Disease Center, Fuwai Hospital
Beijing, Beijing Municipality
About this study
A Clinical Trial of the Transcatheter Aortic Valve Implantation System with a Prospective, Multi-Center, One-Arm Approach to Evaluate the Efficacy and Safety in the Treatment of Patients with Severe Aortic Stenosis
Read the detailed description
This trial consists of two parts. Part I, the Feasibility trial: 10-12 patients with severe aortic stenosis who meet inclusion/exclusion criteria and are at high surgical risk or not suitable for conventional surgical valve replacement are selected at no more than 5 centers for implantation of an aortic valve by transcatheter aortic valve replacement (KOKA-VALVE) to achieve treatment of aortic valve disease in subjects. All-cause mortality at 30 days after implantation is used as the primary endpoint, and the immediate postoperative device success and surgical success, major cardiovascular adverse events at 1 year after implantation, transvalvular pressure difference at 30 days and 12 months after implantation, degree of orifice regurgitation, degree of perivalvular leakage, improvement in NYHA cardiac function, and improvement in quality of survival are used as the secondary endpoints to supplementarily evaluate the safety and feasibility of this product. It also provides experience and reference for further Part II confirmatory trials and applications to ensure safe conduct of confirmatory trials. Subjects in the feasibility trial may continue to be followed up at 6 months after implantation and 12 months after implantation after completion of the one-month postoperative follow-up. All subjects will also continue to be followed up by telephone at 24, 36, 48, and 60 months after implantation.
Part II, the Confirmatory Trial: Designed with a prospective, multi-center, one-arm approach. 131 patients with severe aortic stenosis who meet inclusion/non-exclusion criteria and are at high surgical risk or unsuitable for conventional surgical valve replacement are implanted with an aortic valve by transcatheter aortic valve replacement (KOKA-VALVE) to achieve treatment of aortic valve disease in subjects. All-cause mortality at 30 days after implantation is used as the primary endpoint, and the immediate postoperative device success and surgical success, major cardiovascular adverse events at 1 year after implantation, transvalvular pressure difference at 30 days and 12 months after implantation, degree of orifice regurgitation, degree of perivalvular leakage, improvement in NYHA cardiac function, and improvement in quality of survival are used as the secondary endpoints to supplementarily evaluate the safety and feasibility of this product.
All patients will be followed up before discharge, 30 days, 6 months, and 12 months after implantation after product implantation. All subjects will be followed up by telephone at 24 months, 36 months, 48 months and 60 months after implantation.
The study will be conducted at multiple clinical trial sites nationwide, and 131 subjects will be enrolled in the confirmatory trial. The enrollment and treatment status of the subjects will be recorded during the study, and the subjects will be followed up before discharge, 6 months after implantation, and 12 months after implantation, and the data will be compiled for registration and declaration.
All subjects will be followed up by telephone at 24 months, 36 months, 48 months, and 60 months after implantation.
- Conditions
- Aortic Stenosis
- Being tested
- Transcatheter Aortic Valve Implantation (KOKA-VALVE)
- Keywords
- Heart Valve Disease, Cardiovascular Diseases
- Medical subject headings
- Aortic Valve Stenosis, Heart Valve Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve Implantation (KOKA-VALVE)Device
Transcatheter Aortic Valve Implantation
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Device: Transcatheter Aortic Valve Implantation (KOKA-VALVE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Cumulative all-cause mortality at 12 months postoperatively
Measured: 12 months postoperatively
Secondary outcomes (5)
Transvalvular Gradient
Transvalvular Gradients at 30 days and 12 months postoperatively
Measured: 30 days and 12 months postoperatively
Aortic Regurgitation Degree
Aortic Regurgitation Degree at 30 days and 12 months postoperatively
Measured: 30 days and 12 months postoperatively
Perivalvular Leakage
Perivalvular Leakage at 30 days and 12 months postoperatively
Measured: 30 days and 12 months postoperatively
Cardiac Function
The rate of New York Heart Association (NYHA) Function Class at 30 days and 12 months postoperatively
Measured: 30 days and 12 months postoperatively
Quality of Survival
The score of EQ-5D at 30 days and 12 months postoperatively
Measured: 30 days and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start30 Dec 2022 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai 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
- 131 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Xiangbin Pan, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673525
- Sponsor's protocol ID
- KOKA-2022-03
- Status last verified
- Dec 2022
- First submitted
- 21 Dec 2022
- Last updated
- 6 Jan 2023
- 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 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of the Transcatheter Aortic Valve Implantation System With a Prospective, Multi-Center, One-Arm Approach to Evaluate the Efficacy and Safety in the Treatment of Patients With Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT05673525
- Acronym / sponsor ID
- KOKA-2022-03
- Conditions
- Aortic Stenosis
- Keywords
- Heart Valve Disease, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 131 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 30 Dec 2022 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 6 Jan 2023 (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.
A Clinical Trial of the Transcatheter Aortic Valve Implantation System with a Prospective, Multi-Center, One-Arm Approach to Evaluate the Efficacy and Safety in the Treatment of Patients with Severe Aortic Stenosis
Detailed description
This trial consists of two parts. Part I, the Feasibility trial: 10-12 patients with severe aortic stenosis who meet inclusion/exclusion criteria and are at high surgical risk or not suitable for conventional surgical valve replacement are selected at no more than 5 centers for implantation of an aortic valve by transcatheter aortic valve replacement (KOKA-VALVE) to achieve treatment of aortic valve disease in subjects. All-cause mortality at 30 days after implantation is used as the primary endpoint, and the immediate postoperative device success and surgical success, major cardiovascular adverse events at 1 year after implantation, transvalvular pressure difference at 30 days and 12 months after implantation, degree of orifice regurgitation, degree of perivalvular leakage, improvement in NYHA cardiac function, and improvement in quality of survival are used as the secondary endpoints to supplementarily evaluate the safety and feasibility of this product. It also provides experience and reference for further Part II confirmatory trials and applications to ensure safe conduct of confirmatory trials. Subjects in the feasibility trial may continue to be followed up at 6 months after implantation and 12 months after implantation after completion of the one-month postoperative follow-up. All subjects will also continue to be followed up by telephone at 24, 36, 48, and 60 months after implantation.
Part II, the Confirmatory Trial: Designed with a prospective, multi-center, one-arm approach. 131 patients with severe aortic stenosis who meet inclusion/non-exclusion criteria and are at high surgical risk or unsuitable for conventional surgical valve replacement are implanted with an aortic valve by transcatheter aortic valve replacement (KOKA-VALVE) to achieve treatment of aortic valve disease in subjects. All-cause mortality at 30 days after implantation is used as the primary endpoint, and the immediate postoperative device success and surgical success, major cardiovascular adverse events at 1 year after implantation, transvalvular pressure difference at 30 days and 12 months after implantation, degree of orifice regurgitation, degree of perivalvular leakage, improvement in NYHA cardiac function, and improvement in quality of survival are used as the secondary endpoints to supplementarily evaluate the safety and feasibility of this product.
All patients will be followed up before discharge, 30 days, 6 months, and 12 months after implantation after product implantation. All subjects will be followed up by telephone at 24 months, 36 months, 48 months and 60 months after implantation.
The study will be conducted at multiple clinical trial sites nationwide, and 131 subjects will be enrolled in the confirmatory trial. The enrollment and treatment status of the subjects will be recorded during the study, and the subjects will be followed up before discharge, 6 months after implantation, and 12 months after implantation, and the data will be compiled for registration and declaration.
All subjects will be followed up by telephone at 24 months, 36 months, 48 months, and 60 months after implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Transcatheter Aortic Valve Implantation (KOKA-VALVE) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Contraindication to surgery, or high risk for surgery (STS ≥ 8%) as assessed by the heart team; or other circumstances that make surgical valve replacement inappropriate.
- Age ≥65 years.
- Patients with symptomatic severe aortic stenosis (mean aortic transvalvular gradient by echocardiography ≥40 mmHg (1 mmHg=0.133 kPa), or transaortic flow velocity ≥4.0 m/s, or aortic valve orifice area <0.8 cm2, or effective aortic orifice area index <0.5 cm2 /m2).
- The subjects have been informed of the nature of this study, understand the purpose of the clinical trial, and voluntarily participate in and sign the informed consent form.
Key exclusion criteria (17 listed)
- Life expectancy less than 1 year after implantation of the prosthetic valve.
- Patients had an acute heart attack within 1 month, or had a coronary stent or a pacing device implantation within 1 month, or had any therapeutic cardiac surgery within 1 month.
- Patients with aortic root anatomy and lesion that are not suitable for prosthetic valve implantation.
- Combined with severe insufficiency or stenosis of other valves and requiring surgical treatment.
- Hematologic cachexia, including leukopenia (WBC <3×10^9 /L), acute anemia (HB <90 g/L), thrombocytopenia (PLT <50 × 10^9 /L), bleeding constitution, and coagulation disorders.
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 |
|---|---|---|
| Transcatheter Aortic Valve Implantation (KOKA-VALVE)Transcatheter Aortic Valve Implantation | Device | Treatment Group |
Primary outcome
All-cause mortality
Time frame: 12 months postoperatively
Cumulative all-cause mortality at 12 months postoperatively
5 secondary outcomes
Transvalvular Gradient
Time frame: 30 days and 12 months postoperatively
Aortic Regurgitation Degree
Time frame: 30 days and 12 months postoperatively
Perivalvular Leakage
Time frame: 30 days and 12 months postoperatively
Cardiac Function
Time frame: 30 days and 12 months postoperatively
Quality of Survival
Time frame: 30 days and 12 months postoperatively
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 6 Jan 2023.
- 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.
Xiangbin Pan principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Aortic Valve Implantation (KOKA-VALVE) in people with Aortic Stenosis, run by Chinese Academy of Medical Sciences, Fuwai 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 4 inclusion and 17 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: opening soon, as of the sponsor's last update on 6 Jan 2023. 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?
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?
Contact Chunrui Xiang (+86 17601425727, crxiang@kokalife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 12 months postoperatively). 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 Jan 2023.