Severe Aortic StenosisNCT07304427
Alwide Plus China Post-market Clinical Investigation
An observational study of Severe Aortic Stenosis and Transcatheter Aortic Valve Replacemen, run by Shanghai MicroPort CardioFlow Medtech Co., Ltd. at 4 sites in China.
Trial summary
This is a prospective, single-arm, multi-center, post-market registry study conducted in China. The purpose is to evaluate the safety and effectiveness of the AlwideTM Plus balloon catheter for pre-dilatation of the aortic valve during TAVR in the real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Aortic Stenosis, Transcatheter Aortic Valve Replacemen
- How many people
- 75 participants
- Where
- 4 sitesChina
- Study dates
- 3 Jan 2025to 4 Nov 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering severe aortic stenosis and requiring pre-dilation during TAVR
Who may be able to join
- Age≥18 years old;
- Severe aortic stenosis verified by echocardiogram: mean transvalvular gradient≥40mmHg (1mmHg=0.133kPa), or peak aortic jet velocity≥4m/s, or aortic valve area (AVA) ≤ 1.0cm2 (or AVA index≤ 0.6cm2/m2);
- Patients, who can understand the clinical investigation purpose, voluntary agree and sign the informed consent form, and willing to comply with relevant trial assessments and clinical follow up
Who cannot join
- Aortic valve anatomy or lesion unsuitable or not necessary for balloon pre-dilation during the TAVR procedure
- TAVR procedure in trans-apical access
- Pre-implanted mechanical or bioprosthetic valve at the aortic valve position
- Acute myocardial infarction (MI) occurred in the last 30 days before the treatment；
- LVOT obstruction;
- Serious left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%
Show all 15Show fewer
- Echocardiographic evidence of intracardiac mass, thrombus or neoplasm；
- Unable to receive anticoagulation or antiplatelet therapy；
- Allergy to nitinol or sensitive contrast media；
- Active bacterial endocarditis or other active infection may affect the procedure；
- Aortic valve anatomy , lesion, or other situation unsuitable for the prosthesis valve implantation as assessed by the investigator team；
- Life expectancy > 12 months；
- vulnerable individuals who are unable to give informed consent/ unable to fully understand all aspects of the investigation or Severe incapacitating Alzheimer's disease；
- Patients who participated in other clinic trials of drugs or medical device before being enrolled for which the primary endpoint follow up duration has not been reached；
- Investigators determined that patients have poor compliance and can't complete the study as required
Trial locations and contacts
4 sites in 1 country.
China4 sites
Guangdong Provincial People's Hospital
Guangzhou
Yan'an Hospital of Kunming City
Kunming, Yunnan
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong
About this study
Official title: A Prospective, Multicenter, Post-market Clinical Investigation to Evaluate the Pre-dilation Safety and Effectiveness of Alwide Plus Balloon Catheter of MicroPort CardioFlow in Transcatheter Aortic Valve Replacement
This is a prospective, single-arm, multi-center, post-market registry study conducted in China. The purpose is to evaluate the safety and effectiveness of the AlwideTM Plus balloon catheter for pre-dilatation of the aortic valve during TAVR in the real-world setting.
Read the detailed description
The study is designed to evaluate the safety and effectiveness of the Alwide Plus balloon catheter for pre-dilatation of the aortic valve during in transcatheter aortic valve replacement in the real-world setting, with TAVI device success at immediate post-procedure as the primary endpoint. The immediate post-procedural pre-dilation success, all-cause mortality, stroke, bleeding, acute kidney injury, permanent pacemaker implantation, major vascular complication, valve function at post-procedure and discharge, and post-dilation success will be used as secondary endpoints.This is a prospective, multi-center, post market clinical investigation. 75 patients will be enrolled in this clinical investigation. All subjects will undergo telephone follow-up at 30 days post-procedure.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Alwide Plus | Paitents perfomed TAVR and have Alwlide Plus Balloon Catheter pre-dilaton or post-dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with TAVI device success at immediate post-procedure
TAVI device success, defined as (meeting all the following criteria):
Freedom from mortality; Successful access, delivery, deployment, implantation of the valve, and retrieval of the delivery system; Correct positioning of the prosthetic heart valve into the proper anatomical location; Intended performance of the valves (mean gradient <20mmHg, or peak velocity <3 m/s, and no severe aortic regurgitation or paravalvular leakage).
Measured: Immediate post-procedure
Secondary outcomes (6)
Percentage of patients with balloon pre-dilation success
defined as successful access, delivery and dilation the aortic valve, and retrieval for the AlwideTM Plus balloon catheter
Measured: Immediate post-procedure
Percentage of paitents with balloon post-dilation success
defined as successful access, delivery and dilation the transcatheter aortic valve, and retrieval for the AlwideTM Plus balloon catheter
Measured: Immediate post-procedure
Incidence of all-cause mortality, disabling and non-disabling stroke, life-threatening or disabling bleeding, major bleeding, acute kidney injury(AKIN≥2), major vascular complications and new permanent pacemaker implantation
Definition following VARC-2 criteria
Measured: Immediate post-procedure and 30 days post-procedure
Prosthetic valve performance-mean transvalular pressure gradient
Prosthetic valve performance-mean pressure gradient(assessed by echocardiography), unit -mmHg
Measured: Immediate post-procedure and discharge(within 7 days post-procedure)
Prosthetic valve performance-orifice area
Prosthetic valve performance-orifice area(assessed by echocardiography), unit -cm2
Measured: Immediate post-procedure and discharge(within 7 days post-procedure)
Prosthetic valve performance-valve regurgitation(intra- and para valvular leakage)
Prosthetic valve performance-valve regurgitation(intra- and para valvular leakage), none/trace/mild/moderate/severe
Measured: Immediate post-procedure and discharge(within 7 days post-procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start3 Jan 2025
- Primary completion11 Oct 2025
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Aortic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304427
- Sponsor's protocol ID
- Alwide Plus-2024
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- 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 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Post-market Clinical Investigation to Evaluate the Pre-dilation Safety and Effectiveness of Alwide Plus Balloon Catheter of MicroPort CardioFlow in Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT07304427
- Acronym / sponsor ID
- Alwide Plus-2024
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 11 Oct 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 26 Dec 2025 (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 is a prospective, single-arm, multi-center, post-market registry study conducted in China. The purpose is to evaluate the safety and effectiveness of the AlwideTM Plus balloon catheter for pre-dilatation of the aortic valve during TAVR in the real-world setting.
Detailed description
The study is designed to evaluate the safety and effectiveness of the Alwide Plus balloon catheter for pre-dilatation of the aortic valve during in transcatheter aortic valve replacement in the real-world setting, with TAVI device success at immediate post-procedure as the primary endpoint. The immediate post-procedural pre-dilation success, all-cause mortality, stroke, bleeding, acute kidney injury, permanent pacemaker implantation, major vascular complication, valve function at post-procedure and discharge, and post-dilation success will be used as secondary endpoints.This is a prospective, multi-center, post market clinical investigation. 75 patients will be enrolled in this clinical investigation. All subjects will undergo telephone follow-up at 30 days post-procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alwide Plus | – | –Paitents perfomed TAVR and have Alwlide Plus Balloon Catheter pre-dilaton or post-dilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering severe aortic stenosis and requiring pre-dilation during TAVR
Key inclusion criteria (3 listed)
- Age≥18 years old;
- Severe aortic stenosis verified by echocardiogram: mean transvalvular gradient≥40mmHg (1mmHg=0.133kPa), or peak aortic jet velocity≥4m/s, or aortic valve area (AVA) ≤ 1.0cm2 (or AVA index≤ 0.6cm2/m2);
- Patients, who can understand the clinical investigation purpose, voluntary agree and sign the informed consent form, and willing to comply with relevant trial assessments and clinical follow up
Key exclusion criteria (15 listed)
- Aortic valve anatomy or lesion unsuitable or not necessary for balloon pre-dilation during the TAVR procedure
- TAVR procedure in trans-apical access
- Pre-implanted mechanical or bioprosthetic valve at the aortic valve position
- Acute myocardial infarction (MI) occurred in the last 30 days before the treatment；
- LVOT obstruction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients with TAVI device success at immediate post-procedure
Time frame: Immediate post-procedure
TAVI device success, defined as (meeting all the following criteria): Freedom from mortality; Successful access, delivery, deployment, implantation of the valve, and retrieval of the delivery system; Correct positioning of the prosthetic heart valve into the proper anatomical location; Intended performance of the valves (mean gradient <20mmHg, or peak velocity <3 m/s, and no severe aortic regurgitation or paravalvular leakage).
6 secondary outcomes
Percentage of patients with balloon pre-dilation success
Time frame: Immediate post-procedure
Percentage of paitents with balloon post-dilation success
Time frame: Immediate post-procedure
Incidence of all-cause mortality, disabling and non-disabling stroke, life-threatening or disabling bleeding, major bleeding, acute kidney injury(AKIN≥2), major vascular complications and new permanent pacemaker implantation
Time frame: Immediate post-procedure and 30 days post-procedure
Prosthetic valve performance-mean transvalular pressure gradient
Time frame: Immediate post-procedure and discharge(within 7 days post-procedure)
Prosthetic valve performance-orifice area
Time frame: Immediate post-procedure and discharge(within 7 days post-procedure)
Prosthetic valve performance-valve regurgitation(intra- and para valvular leakage)
Time frame: Immediate post-procedure and discharge(within 7 days post-procedure)
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 26 Dec 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Aortic Stenosis and Transcatheter Aortic Valve Replacemen, run by Shanghai MicroPort CardioFlow Medtech Co., Ltd. at 4 sites 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 3 inclusion and 15 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: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Percentage of patients with TAVI device success at immediate post-procedure (time frame: Immediate post-procedure). 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 26 Dec 2025.