A Clinical Trial of the Transcatheter Aortic Valve Implantation System With a Prospective, Multi-Center, One-Arm Approach to Evaluate the Efficacy and Safety in the Treatment of Patients With Severe Aortic Stenosis
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Contact the study team: see the registry record → Contacts and Locations
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- Who runs it
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Trial code
- NCT05673525
- Record updated
- 6 January 2023
- Original description
A Clinical Trial of the Transcatheter Aortic Valve Implantation System with a Prospective, Multi-Center, One-Arm Approach to Evaluate the Efficacy and Safety in the Treatment of Patients with Severe Aortic StenosisRead full original descriptionShow less
A Clinical Trial of the Transcatheter Aortic Valve Implantation System with a Prospective, Multi-Center, One-Arm Approach to Evaluate the Efficacy and Safety in the Treatment of Patients with Severe Aortic Stenosis
Inclusion: Contraindication to surgery, or high risk for surgery (STS ≥ 8%) as assessed by the heart team; or other circumstances that make surgical valve replacement inappropriate; Age ≥65 years; Patients with symptomatic severe aortic stenosis (mean aortic transvalvular gradient by echocardiography ≥40 mmHg (1 mmHg=0.133 kPa), or transaortic flow velocity ≥4.0 m/s, or aortic valve orifice area <0.8 cm2, or effective aortic orifice area index <0.5 cm2 /m2); The subjects have been informed of the nature of this study, understand the purpose of the clinical trial, and voluntarily participate in and sign the informed consent form.
Exclusion: Patients who cannot tolerate anticoagulation or antiplatelet therapy; Currently participating in an investigational drug or another device study that has not completed its primary endpoints or would clinically interfere with the endpoint of this study; Other circumstances that are assessed by the investigator to be unsuitable for interventional aortic valve therapy; Patients had an acute heart attack within 1 month, or had a coronary stent or a pacing device implantation within 1 month, or had any therapeutic cardiac surgery within 1 month; Combined with severe insufficiency or stenosis of other valves and requiring surgical treatment; Untreated coronary artery disease requiring hematologic reconstruction; Severe right ventricular insufficiency; Patients had cerebrovascular event (CVA), including ischemic stroke and hemorrhagic stroke within 3 months; Decompensation of renal insufficiency; Active infective endocarditis or other active infection; Untreated conduction system disease requiring pacemaker implantation; Hematologic cachexia, including leukopenia (WBC <3×10\^9 /L), acute anemia (HB <90 g/L), thrombocytopenia (PLT <50 × 10\^9 /L), bleeding constitution, and coagulation disorders; Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%; Life expectancy less than 1 year after implantation of the prosthetic valve; Patients with aortic root anatomy and lesion that are not suitable for prosthetic valve implantation; Hypertrophic obstructive cardiomyopathy; The existent of intracardiac masses, thrombi or superfluous organisms by echocardiography.