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Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis
Condition(s) studied
Aortic Stenosis Symptomatic
Investigational drug(s) / intervention(s)
transcatheter aortic valve replacement in severe aortic stenosis
transcatheter aortic valve replacement in severe aortic stenosis: transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis
Study 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
Eligibility
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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;
* 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.
Primary outcome measure(s)
- Device success rate — 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)
Trial sites (1)
| Facility | City | Region | Status |
| Peiga Medical Technology (Suzhou) Co., Ltd, Suzhou, Jiangsu 215025 |
Suzhou |
Jiangsu |
|
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