Status:
ENROLLING_BY_INVITATION
Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System
Lead Sponsor:
Lepu Medical Technology (Beijing) Co., Ltd.
Conditions:
Transcatheter Aortic Valve Replacement
Eligibility:
All Genders
65+ years
Phase:
NA
Brief 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 sever...
Detailed Description
This prospective, single-center, single-arm clinical trial was designed to preliminary confirm the safety and efficacy of SinocrownTM transcatheter aortic valve system with accessories. According to ...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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;
- Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \<20%;
- The echocardiogram indicates the presence of a thrombus or vegetation;
- A history of active peptic ulcer or upper gastrointestinal bleeding within 3 months;
- Are allergic to nickel titanium alloys or contrast agents, and cannot tolerate anticoagulation and antiplatelet therapy;
- Cerebrovascular accident occurred within 6 months, including transient ischemic attack;
- renal insufficiency(creatinine\> 3.0mg/dL) and/or end-stage renal disease requiring Renal dialysis;
- Life expectancy\< 12 months;
- Significant aortic diseases, including abdominal aortic or thoracic aortic aneurysm(defined as maximum lumen diameter \> 50mm, obvious distortion), atherosclerosis of the aortic arch(especially bulge with thickness \> 5mm or ulceration), narrowing of the abdominal or thoracic aorta(especially calcification and irregular surface), and severe curvature of the thoracic aorta;
- The iliac-femoral artery cannot be inserted with a guide sheath of 22F or above, such as severely obstructed with calcification, severely tortuous or vessel diameter less than 6mm;
- Screening participant who is participating in other drug or medical device clinical trials;
- Active infective endocarditis or other active infections;
- Anatomically, the approach or aortic root is not suitable for TAVR (such as a high risk of coronary artery occlusion).
- Other conditions considered by the investigator to be inappropriate for participation in this clinical trial.
Key Trial Info
Start Date :
April 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05202977
Start Date
April 6 2021
End Date
August 1 2026
Last Update
January 24 2022
Active Locations (1)
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1
Hefei High-tech Cardiovascular hospital
Hefei, Anhui, China