Aortic Valve StenosisNCT04836897
PrizValve® Transcatheter Aortic Valve Replacement Study
A study testing PrizValve® valve and transapical delivery system in people with Aortic Valve Stenosis, run by Shanghai NewMed Medical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not suitable for surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- PrizValve® valve and transapical delivery system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2021to Jun 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
- Age ≥ 65 years ;
- Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography: transaortic valve pressure gradient ≥40mmHg (1mmHg=0.133kPa), or transaortic valve blood flow rate ≥4m/s, or aortic Valve area<1.0cm2, or AVA <0.5cm2 /m2);
- NYHA ≥ II;
- Life expectancy> 12 months;
- Patients who are anatomically suitable for transcatheter aortic valve implantation;
- After evaluation by two or more cardiovascular surgeons, patients who are unsuitable for surgery; or patients who refuse surgery after sufficient communication by the surgeons and are at high risk of routine surgery;
- Patients who can understand the purpose of the trial, voluntarily participate in and signed informed consent form, and are willing to accept relevant examinations and clinical follow-ups.
Who cannot join
- Acute myocardial infarction occurred within 1 month before this treatment;
- Congenital single leaf aortic valve;
- Any therapeutic cardiac operation (including placement of coronary drug-eluting stents) within 30 days;
- The patient's heart has been implanted with other artificial heart valves, artificial rings, or severe mitral regurgitation (>3+);
- Blood system diseases or abnormalities, including leukopenia (WBC<3×109/L), acute anemia (HB <90g/L), thrombocytopenia (PLT<50×109/L), bleeding constitution and coagulopathy ；
- Untreated severe coronary artery stenosis that requires revascularization;
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- Patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation;
- Patients who need emergency surgery for any reason;
- Hypertrophic cardiomyopathy with obstruction;
- Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%;
- The echocardiogram indicates the presence of a heart mass, thrombus or vegetation;
- A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;
- Are allergic to cobalt-chromium alloys or contrast agents, and cannot tolerate anticoagulation and antiplatelet therapy;
- The diameter of the aortic valve annulus <16mm or >28mm;
- In any case, patients who refuse surgical treatment in emergency situations;
- Cerebrovascular accident occurred within 3 months, not including transient ischemic attack;
- Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, obvious curvature of the aortic arch, atherosclerosis of the aortic arch, narrowing of the abdominal or thoracic aorta, and obvious curvature or extension of the thoracic aorta;
- The iliac-femoral artery is severely obstructed with calcification, severely tortuous or unable to place the 1418F catheter sheath kit;
- Active infective endocarditis or other active infections;
- Aortic valve leaflets calcified plaque close to the coronary ostium;
- Severe disability Alzheimer's disease and unable to take care of oneself in life;
- Those who have participated in clinical trials of other drugs or medical devices before entering the group and have not yet reached the time limit of the primary research endpoint;
- The researcher judged that the patient had poor compliance and could not complete the study as required.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Cardiology, West China Hospital, Sichuan University
Sichuan
About this study
Official title: Evaluation of the Efficacy and Safety of the Transcatheter Aortic Valve Replacement System in Patients With Severe Aortic Valve Stenosis Disease at High Surgical Risk
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not suitable for surgery.
Read the detailed description
This study is an multicenter, single-arm, prospective, safety and performance clinical study.
- Conditions
- Aortic Valve Stenosis
- Being tested
- PrizValve® valve and transapical delivery system
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrizValve® valve and transapical delivery systemDevice
Transcatheter aortic valve replacement system
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Transcatheter aortic valve replacement Receives: Device: PrizValve® valve and transapical delivery system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from all-cause mortality
All-cause mortality within 12 months of TAVI procedure
Measured: 12 months
Secondary outcomes (6)
Freedom from all-cause mortality
All-cause mortality within 2-5 years of TAVI procedure
Measured: 2-5 years
Device success
Device success after TAVI
Measured: immediate post-surgical
Procedural success
Procedural success after TAVI
Measured: immediate post-surgical
Rate of Myocardial infarction
Rate of Myocardial infarction after TAVI
Measured: 30 days、6 months、1-5 years
Rate of All disabling stroke
Rate of All disabling stroke after TAVI
Measured: 30 days、6 months、1-5 years
Rate of Severe bleeding
Rate of Severe bleeding after TAVI
Measured: 30 days、6 months、1-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start19 Jan 2021
- Primary completion19 Jun 2023
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai NewMed Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chen mao, Chief, Study chair, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836897
- Sponsor's protocol ID
- A-valve-2020-07
- Status last verified
- Nov 2023
- First submitted
- 6 Apr 2021
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of the Transcatheter Aortic Valve Replacement System in Patients With Severe Aortic Valve Stenosis Disease at High Surgical Risk
- ClinicalTrials.gov ID
- NCT04836897
- Acronym / sponsor ID
- A-valve-2020-07
- Conditions
- Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai NewMed Medical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- Jun 2028 (estimated)
- First posted
- 8 Apr 2021 (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 purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not suitable for surgery.
Detailed description
This study is an multicenter, single-arm, prospective, safety and performance clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: PrizValve® valve and transapical delivery systemTranscatheter aortic valve replacement |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age ≥ 65 years ;
- Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography: transaortic valve pressure gradient ≥40mmHg (1mmHg=0.133kPa), or transaortic valve blood flow rate ≥4m/s, or aortic Valve area<1.0cm2, or AVA <0.5cm2 /m2);
- NYHA ≥ II;
- Life expectancy> 12 months;
- Patients who are anatomically suitable for transcatheter aortic valve implantation;
Key exclusion criteria (23 listed)
- Acute myocardial infarction occurred within 1 month before this treatment;
- Congenital single leaf aortic valve;
- Any therapeutic cardiac operation (including placement of coronary drug-eluting stents) within 30 days;
- The patient's heart has been implanted with other artificial heart valves, artificial rings, or severe mitral regurgitation (>3+);
- Blood system diseases or abnormalities, including leukopenia (WBC<3×109/L), acute anemia (HB <90g/L), thrombocytopenia (PLT<50×109/L), bleeding constitution and coagulopathy ；
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 |
|---|---|---|
| PrizValve® valve and transapical delivery systemTranscatheter aortic valve replacement system | Device | Treatment |
Primary outcome
Freedom from all-cause mortality
Time frame: 12 months
All-cause mortality within 12 months of TAVI procedure
6 secondary outcomes
Freedom from all-cause mortality
Time frame: 2-5 years
Device success
Time frame: immediate post-surgical
Procedural success
Time frame: immediate post-surgical
Rate of Myocardial infarction
Time frame: 30 days、6 months、1-5 years
Rate of All disabling stroke
Time frame: 30 days、6 months、1-5 years
Rate of Severe bleeding
Time frame: 30 days、6 months、1-5 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 15 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruitingPhase 4
Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
Aortic Stenosis, Severe Aortic Stenosis
Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
Aortic Valve Stenosis, Hypertrophy, Left Ventricular
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.
Chen mao, Chief study chair
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrizValve® valve and transapical delivery system in people with Aortic Valve Stenosis, run by Shanghai NewMed Medical Co., Ltd. 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 7 inclusion and 23 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 15 Nov 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?
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?
Freedom from all-cause mortality (time frame: 12 months). 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 15 Nov 2023.