Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology… (NCT06721676) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis
China10 participantsStarted 2024-12
Plain-language 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
Who can participate
Age range60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, su…
What they're measuring
1
Device success rate
Timeframe: at 30 days
Trial details
NCT IDNCT06721676
SponsorPeijia Medical Technology (Suzhou) Co., Ltd.