Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System (NCT05202977) | Clinical Trial Compass
By InvitationNot Applicable
Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System
China10 participantsStarted 2021-04-06
Plain-language summary
This study was designed to preliminary verify the safety and of efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System With accessories in patients with symptomatic, calcified and severe aortic stenosis using objective performance criteria
Who can participate
Age range65 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
✓. Age ≥ 65 years ;
✓. Autologous degenerative aortic stenosis（evaluated by echocardiography: transaortic valve pressure gradient ≥40mmHg , or transaortic valve blood flow rate ≥4m/s, or aortic Valve area\<1.0cm2, or AVA \<0.5cm2 /m2）
✓. Patients with aortic annulus size≥17.5mm and ≤29mm (echocardiography measurement);
✓. The diameter of the ascending aorta of the patient was \< 45mm.
✓. Appear obvious symptoms caused by aortic stenosis, NYHA class Ⅱ to IV;
✓. Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
✓. Subjects are willing to accept all clinical follow-up.
✓. The cardiologist and cardiac surgeon evaluated the subject as unsuitable for surgical treatment (the risk of death or irreversible complications within 30 days after operation is expected to be above 50% , or contraindicated comorbidities such as prior chest radiotherapy, liver failure, diffuse severe calcification of the aorta, extreme weakness, etc.). Or Moderate or higher surgical risk (STS score ≥ 4%).
Exclusion criteria
✕. defined as Q-wave myocardial infarction or non-Q-wave myocardial infarction with CK-MB level ≥ 2 times the upper limit of normal value and / or Tn increase.
✕. Subjects with congenital unicuspid, without calcification.
What they're measuring
1
device success
Timeframe: immediate post-surgical
Trial details
NCT IDNCT05202977
SponsorLepu Medical Technology (Beijing) Co., Ltd.
. Any therapeutic or traumatic cardiac surgery within 30 days (within 3 months in case of drug-eluting stents implantation)
✕. The patient's heart has been implanted with other artificial heart valves, artificial rings, or severe mitral annulus calcification (MAC), severe (\> 3 +) mitral insufficiency.
✕. Hematological abnormalities, including leukopenia (WBC\<3×109/L), acute anemia (HB \<90g/L), thrombocytopenia (PLT\<50×109/L), bleeding constitution and coagulopathy ；
✕. Subjects with hemodynamic instability, requiring continuous mechanical heart assistance.
✕. Subjects who need emergency surgery for any reason;
✕. Hypertrophic cardiomyopathy with or without obstruction;