Use of the Transcatheter Aortic Valve Replacement Surgical Assist System and its Disposable Kit in Patients With Severe Aortic Stenosis to Evaluate the Safety and Efficacy of the Transcatheter Aortic Valve Replacement Surgical Assist System and its Disposable Kit for Use as an Adjunct to Transcatheter Aortic Valve Replacement
Who can participate
Age range
65 Years – 100 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 ≥65 years old, gender is not limited;
* Patients assessed by a cardiac multidisciplinary team (MDT) expert panel as having severe aortic stenosis and suitable for transcatheter aortic valve replacement;
\*Severe aortic stenosis was defined as echocardiographically demonstrated transaortic valve flow velocity ≥4.0 m/s, or transaortic valve pressure differential ≥40 mmHg (1 mmHg=0.133 kPa), or aortic orifice area \<1.0 cm2, or effective aortic orifice area index \<0.6 cm2/m2; for low-pressure-differential-low-flow rate by dopa-phenobutylamine loading test, Doppler ultrasound evaluation or other imaging means of assessment for those judged to have severe aortic stenosis.
* Have a core laboratory assessment that the patient is anatomically suitable for transcatheter aortic valve replacement;
* Patients who understand the purpose of the trial, voluntarily participate in the trial, sign an informed consent form, and are willing to cooperate in the follow-up.
Exclusion Criteria:
* Patients whose access or aortic root anatomical pattern is unsuitable for TAVR treatment;
* Poor peripheral arterial conditions that preclude transfemoral TAVR;
* Aortic annulus horizontal pinch angle ≥65° as measured by preoperative MDCT;
* Patients at high risk of coronary obstruction requiring intraoperative coronary protection measures;
* Patients requiring intraoperative delivery with a grapple assist system;
* Previous implantation of a prosthetic aortic valve (biopros…
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
Technical Success at exit from OR, hybrid room or cath lab post-index procedure
Timeframe: Immediate after procedure
Trial details
NCT IDNCT07392359
SponsorZhicheng Medical Technology (Jiaxing) Co, Ltd