Alwide Plus China Post-market Clinical Investigation (NCT07304427) | Clinical Trial Compass
CompletedNot Applicable
Alwide Plus China Post-market Clinical Investigation
China75 participantsStarted 2025-01-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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%
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of patients with TAVI device success at immediate post-procedure