Aortic Stenosis SymptomaticNCT06721676
Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis
A study testing transcatheter aortic valve replacement in severe aortic stenosis in people with Aortic Stenosis Symptomatic, run by Peijia Medical Technology (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medical Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aortic Stenosis Symptomatic
- What is being tested?
- transcatheter aortic valve replacement in severe aortic stenosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Dec 2024to 30 Jun 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are willing to participate and sign the informed consent and can cooperate with the whole trial process;
- Age ≥60 years old;
- Patients with severe calcified aortic stenosis confirmed by echocardiography (trans-aortic valve flow velocity ≥ 4.0m /s, or trans-active valvular pressure difference ≥40mmHg (1mmHg=0.133kPa), or aortic valve orientation area < 0.8cm2, or effective aortic valve orifice the product index is < 0.5cm2/m2);
- The cardiac team (at least two specialists in cardiovascular surgery) assessed the patient as unsuitable for routine surgery ;
- The aortic angel ≥60 degree.
Who cannot join
- The left and right coronary ostiums originate from the junctional zone or from both coronary ostiums;
- previous CABG history;
- Coronary ostial lesions（PCI or not）;
- Prior aortic valve prosthesis implantation (interventional/surgical, bioprosthetic/mechanical);
- Spoor peripheral arterial condition precluded transfemoral TAVR;
- Severe coronary stenoses requiring intervention for which concomitant PCI is not possible;
Show all 14Show fewer
- Concomitant diseases requiring cardiac surgery;
- Other serious diseases that may reduce life expectancy to less than 12 months (e.g. clinically recurrent or metastatic cancer, congestive heart failure, etc.);
- contraindications to conventional cardiac catheterization, such as intracardiac thrombosis, infection, outflow obstruction, hypertrophic cardiomyopathy, etc;
- other surgical anatomical contraindications, such as the risk of coronary artery occlusion;
- clinically significant active bleeding
- platelet count < 30×10/ L;
- participating in other drug or medical device clinical studies that have not yet been completed ;
- considered inappropriate by the investigator to participate in the clinical study.
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
Peiga Medical Technology (Suzhou) Co., Ltd, Suzhou, Jiangsu 215025
Suzhou, Jiangsu, 215025
jing jing, 18550112597, renjing@peijiamedical.com
daxin zhou, professor
About this study
Official title: A Prospective, Single-center, Single-group Follow-up Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis by Peijia Medical
A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medical
Read the detailed description
A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medica.Patients are seen at pre and post procedure, discharge, 30 days. The main follow-up included clinical symptoms and signs, cardiac ultrasound, CT, etc. The outcome include immediate device success, procedure success and device sucess. The secondary end points include ：1) Immediate postoperative ultrasound evaluation of different sinus valve implantation depths.2) realization rate of commissural alignment was evaluated by ultrasound immediately after operation.3) the incidence of ≥ moderate paravalvular regurgitation assessed by ultrasound at 30 days after surgery.
- CT assessment of different sinus valve implantation depths at 30 days after surgery.5) CT was performed 30 days after operation to evaluate the realization rate of commissural alignment and coronary artery alignment
- Conditions
- Aortic Stenosis Symptomatic
- Being tested
- transcatheter aortic valve replacement in severe aortic stenosis
- Keywords
- aortic stenosis, TAVI, TAVR, Function of bending
- 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.
transcatheter aortic valve replacement in severe aortic stenosisDevice
transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis
| Study group | Role | What they receive |
|---|---|---|
| A single arm study | Experimental | The experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system.the transporter has A2 flex function to improve coaxiality and commissural aligment to reduce coronary occlusion Receives: Device: transcatheter aortic valve replacement in severe aortic stenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device success rate
Device success is defined as - Vascular access, artificial aortic valve delivery and release were successful, and the delivery catheter was successfully withdrawn. - The artificial aortic valve was implanted in an anatomically accurate position. - The artificial aortic valve met the expected requirements (mean transvalvular pressure difference < 20mmHg or maximum flow rate < 3m/s; Doppler velocity index >_0.25,and less than moderate aortic regurgitation)
Measured: at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study startDec 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic Stenosis SymptomaticStudies 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
- Model description
- Transcatheter aortic valve system 2.5 generation is a new self-expanding valve system developed by Peijia Medical. Through the improvement of the delivery device to achieve A2 flex and commissural alignment technology, it can better manage the whole life cycle of AS patients
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Zhongshan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721676
- Sponsor's protocol ID
- B2024-496
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.
PubMed 30883058Vinayak M, Tang GHL, Li K, Berdan M, Koshy AN, Khera S, Lerakis S, Dangas GD, Sharma SK, Kini AS, Krishnamoorthy P. Commissural vs Coronary Alignment to Avoid Coronary Overlap With THV-Commissure in TAVR: A CT-Simulation Study. JACC Cardiovasc Interv. 2024 Mar 25;17(6):715-726. doi: 10.1016/j.jcin.2024.01.073. Epub 2024 Mar 6.
PubMed 38456886Bieliauskas G, Wong I, Bajoras V, Wang X, Kofoed KF, De Backer O, Sondergaard L. Patient-Specific Implantation Technique to Obtain Neo-Commissural Alignment With Self-Expanding Transcatheter Aortic Valves. JACC Cardiovasc Interv. 2021 Oct 11;14(19):2097-2108. doi: 10.1016/j.jcin.2021.06.033. Epub 2021 Sep 15.
PubMed 34538602
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Single-group Follow-up Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis by Peijia Medical
- ClinicalTrials.gov ID
- NCT06721676
- Acronym / sponsor ID
- B2024-496
- Conditions
- Aortic Stenosis Symptomatic
- Keywords
- aortic stenosis, TAVI, TAVR, Function of bending
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Zhongshan Hospital
- Study start
- Dec 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 6 Dec 2024 (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 prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medical
Detailed description
A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medica.Patients are seen at pre and post procedure, discharge, 30 days. The main follow-up included clinical symptoms and signs, cardiac ultrasound, CT, etc. The outcome include immediate device success, procedure success and device sucess. The secondary end points include ：1) Immediate postoperative ultrasound evaluation of different sinus valve implantation depths.2) realization rate of commissural alignment was evaluated by ultrasound immediately after operation.3) the incidence of ≥ moderate paravalvular regurgitation assessed by ultrasound at 30 days after surgery.
- CT assessment of different sinus valve implantation depths at 30 days after surgery.5) CT was performed 30 days after operation to evaluate the realization rate of commissural alignment and coronary artery alignment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Transcatheter aortic valve system 2.5 generation is a new self-expanding valve system developed by Peijia Medical. Through the improvement of the delivery device to achieve A2 flex and commissural alignment technology, it can better manage the whole life cycle of AS patients
| Arm | Type | Receives |
|---|---|---|
| A single arm study | Experimental | Device: transcatheter aortic valve replacement in severe aortic stenosisThe experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system.the transporter has A2 flex function to improve coaxiality and commissural aligment to reduce coronary occlusion |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who are willing to participate and sign the informed consent and can cooperate with the whole trial process;
- Age ≥60 years old;
- Patients with severe calcified aortic stenosis confirmed by echocardiography (trans-aortic valve flow velocity ≥ 4.0m /s, or trans-active valvular pressure difference ≥40mmHg (1mmHg=0.133kPa), or aortic valve orientation area < 0.8cm2, or effective aortic valve orifice the product index is < 0.5cm2/m2);
- The cardiac team (at least two specialists in cardiovascular surgery) assessed the patient as unsuitable for routine surgery ;
- The aortic angel ≥60 degree.
Key exclusion criteria (14 listed)
- The left and right coronary ostiums originate from the junctional zone or from both coronary ostiums;
- previous CABG history;
- Coronary ostial lesions（PCI or not）;
- Prior aortic valve prosthesis implantation (interventional/surgical, bioprosthetic/mechanical);
- Spoor peripheral arterial condition precluded transfemoral TAVR;
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 replacement in severe aortic stenosistranscatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis | Device | A single arm study |
Primary outcome
Device success rate
Time frame: at 30 days
Device success is defined as - Vascular access, artificial aortic valve delivery and release were successful, and the delivery catheter was successfully withdrawn. - The artificial aortic valve was implanted in an anatomically accurate position. - The artificial aortic valve met the expected requirements (mean transvalvular pressure difference < 20mmHg or maximum flow rate < 3m/s; Doppler velocity index >_0.25,and less than moderate aortic regurgitation)
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 Dec 2024.
- Results publication: PubMed 30883058Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.
- Results publication: PubMed 38456886Vinayak M, Tang GHL, Li K, Berdan M, Koshy AN, Khera S, Lerakis S, Dangas GD, Sharma SK, Kini AS, Krishnamoorthy P. Commissural vs Coronary Alignment to Avoid Coronary Overlap With THV-Commissure in TAVR: A CT-Simulation Study. JACC Cardiovasc Interv. 2024 Mar 25;17(6):715-726. doi: 10.1016/j.jcin.2024.01.073. Epub 2024 Mar 6.
- Results publication: PubMed 34538602Bieliauskas G, Wong I, Bajoras V, Wang X, Kofoed KF, De Backer O, Sondergaard L. Patient-Specific Implantation Technique to Obtain Neo-Commissural Alignment With Self-Expanding Transcatheter Aortic Valves. JACC Cardiovasc Interv. 2021 Oct 11;14(19):2097-2108. doi: 10.1016/j.jcin.2021.06.033. Epub 2021 Sep 15.
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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.
Peiga Medical Technology (Suzhou) Co., Ltd, Suzhou, Jiangsu 215025
Suzhou, China
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 replacement in severe aortic stenosis in people with Aortic Stenosis Symptomatic, run by Peijia Medical Technology (Suzhou) 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 5 inclusion and 14 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 Dec 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device success rate (time frame: at 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06721676, which also lists 3 linked publications.
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 Dec 2024.