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Clinical evaluation of safety and efficacy of retrievable transcatheter aortic valve implantation device for the treatment of severe aortic regurgitation: a prospective, multicenter study

Clinical evaluation of safety and efficacy of retrievable transcatheter aortic valve implantation device for the treatment of severe aortic regurgitation: a prospective, multicenter study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057875
Enrollment
Unknown
Registered
2022-03-20
Start date
2022-03-22
Completion date
Unknown
Last updated
2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic regurgitation

Interventions

Sponsors

Union hospital tongji medical college huazhong university of science and technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The diagnosis of echocardiography was severe aortic insufficiency; 2. Age = 60 years; 3. Comply with AVR indications: 1) symptomatic AR; 2) No symptoms of heart failure+LVEF65mm or LVESD>50mm or LVESD/BSA>25mm/cm2; 4. According to the evaluation of the core laboratory, the anatomical structure of the aortic root is suitable for percutaneous TAVR; 5. Patients who are evaluated by two or more cardiovascular specialists as unsuitable or intolerant of surgery (any of the following): 1) STS score = 6%; 2). There are two or more serious irreversible major organ damage, such as heart disease, brain disease, lung disease, liver disease, kidney disease, blood coagulation disorder, malignant tumor, etc; 3). The patient is weak and cannot tolerate surgery; 4) Other surgical operation obstacles such as thoracic deformity, porcelain aorta, post bypass surgery, etc; 6. Patients who can understand the purpose of the study, voluntarily participate in and sign the informed consent form, and are willing to accept relevant examinations and clinical follow-up.

Exclusion criteria

Exclusion criteria: 1. Combined with other cardiovascular diseases requiring surgical operation at the same time, such as aortic dissection, coronary heart disease and three branch disease; 2. Complicated with moderate or above aortic stenosis; 3. Life expectancy<1 year; 4. Contraindication of antithrombotic therapy; 5. Arterial root anatomy and lesions are not suitable for artificial valve implantation; 6. Anatomical morphology or vascular diseases affecting the instrument approach; 7. Left ventricular thrombus; 8. Infectious endocarditis in the active period or other infections that the researcher thinks affect the operation; 9. The investigator judged that the patient or family members had poor compliance or refused (such as senile dementia) and could not complete the study as required.

Design outcomes

Primary

MeasureTime frame
composite end point of all cause mortality, stroke and heart failure related rehospitalization rate;

Countries

China

Contacts

Public ContactNianguo Dong

Union hospital tongji medical college huazhong university of science and technology

14236338@qq.com+86 18827338233

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026