Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis
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- How often do I need to come in, and for how long each time?
- Are travel costs paid?
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- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
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- Who runs it
- Peijia Medical Technology (Suzhou) Co., Ltd.
- Trial code
- NCT06721676
- Record updated
- 6 December 2024
- Original description
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 MedicalRead full original descriptionShow less
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
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
Inclusion: 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: previous CABG history; Prior aortic valve prosthesis implantation (interventional/surgical, bioprosthetic/mechanical); Severe coronary stenoses requiring intervention for which concomitant PCI is not possible; Concomitant diseases requiring cardiac surgery; other surgical anatomical contraindications, such as the risk of coronary artery occlusion; participating in other drug or medical device clinical studies that have not yet been completed ; Spoor peripheral arterial condition precluded transfemoral TAVR; 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; clinically significant active bleeding; platelet count < 30×10/ L; The left and right coronary ostiums originate from the junctional zone or from both coronary ostiums; Coronary ostial lesions（PCI or not）; considered inappropriate by the investigator to participate in the clinical study.