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Clinical Trials in China / NCT06721676
Starting soon Not applicable

Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis

NCT06721676 · tracked via the Priya Life Science China tracker
Sponsor
Peijia Medical Technology (Suzhou) Co., Ltd.
Phase
Not applicable
Started
2024-12
Last updated
2024-12-06

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

Sex
ALL
Min age
60 Years
Max age
Healthy volunteers
No
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)

Trial sites (1)

FacilityCityRegionStatus
Peiga Medical Technology (Suzhou) Co., Ltd, Suzhou, Jiangsu 215025 Suzhou Jiangsu

More Peijia Medical Technology (Suzhou) Co., Ltd. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06721676 on ClinicalTrials.gov ↗ ← All trials in China