Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calci⦠(NCT04815785) | Clinical Trial Compass
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Safety and Efficacy of TaurusOneĀ® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
China120 participantsStarted 2017-09-22
Plain-language summary
To observe and evaluate the safety and efficacy of TaurusOneĀ® transcatheter aortic valve system in patients with severe calcific aortic stenosis through a prospective, multicenter clinical trial using objective performance criteria.
Who can participate
Age range70 Years
SexALL
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Inclusion Criteria:
* Patients who voluntarily participate and sign the informed consent and are able to comply with the entire trial process;
* Age ā„ 70 years;
* Patients with severe calcific aortic stenosis confirmed by echocardiography (Transaortic flow velocity ā„ 4.0 m/s, or aortic-valve gradient ā„ 40 mmHg (1 mmHg = 0.133 kPa), or aortic valve area \< 0.8 cm2, or effective orifice area \< 0.5 cm2/m2);
* Patients who have symptoms obviously caused by aortic stenosis, NYHA Class II or worse;
* Patients who are unsuitable for conventional surgery evaluated by the cardiac team (including at least two cardiovascular surgeons) \[13\] \*;
* Life expectancy after implantation of prosthetic valve is more than one year evaluated by the cardiac team (including at least two cardiac surgeons);
* Aortic annulus diameter ℠18 mm and ⤠29 mm (measured by cardiac CT);
* Ascending aorta diameter \< 50 mm
\*: If the patient meets any of the following criteria judged by a multidisciplinary cardiac team composed of cardiologists and cardiovascular surgeons, radiologists, anesthesiologists, etc. (at least two cardiovascular surgeons), the patient will be identified as unsuitable for conventional surgery (at least STS ā„ 8 points):
* Estimated risk of surgery-related death or disability \> 50% within 1 year;
* ā„3 major organ damage that could not be improved by surgery;
* Obstacles related to surgical procedures judged as serious
Exclusion Criteria:
* Patients with bacteremia or toxemia;
*ā¦
What they're measuring
1
All-cause mortality at 12 months
Timeframe: 12 months
Trial details
NCT IDNCT04815785
SponsorPeijia Medical Technology (Suzhou) Co., Ltd.