Status:
UNKNOWN
Safety and Feasibility of TRISKELE in Severe AS
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Aortic Valve Disease
Eligibility:
All Genders
70+ years
Phase:
NA
Brief Summary
This clinical study is a prospective、single arm and exploratory study, to explore the feasibility and safety of MitrAssist TRISKELE® transcatheter aortic valve system in the treatment of patients with...
Detailed Description
This study was a prospective、single arm clinical trial design. For patients with surgical contraindications or high-risk symptomatic severe aortic stenosis, MitrAssist TRISKELE® transcatheter aortic v...
Eligibility Criteria
Inclusion
- Age ≥ 70 years old;
- Patients with symptomatic severe aortic stenosis (echocardiographic mean pressure gradient across aortic valve ≥ 40mmhg, or blood flow velocity across aortic valve ≥ 4.0m/s, or aortic valve area \< 0.8cm2, or effective aortic valve area index \< 0.5cm2/m2);
- Patients with biological valve decay meeting the criteria in (2) above;
- NYHA grade ≥ grade II;
- The life expectancy after artificial valve implantation is more than 1 year;
- Patients who are anatomically suitable for transcatheter aortic valve implantation;
- Two or more cardiothoracic surgeons evaluate and record it as surgical contraindication or as high-risk surgery and unsuitable for routine surgery;
- Patients who can understand the purpose of the trial, voluntarily participate in and sign informed consent, and are willing to accept relevant examination and clinical follow-up.
Exclusion
- Acute myocardial infarction occurred within 30 days before this treatment (WHO definition: Q-wave MI, or non-Q-wave MI with elevated creatine kinase isoenzyme and troponin T);
- Patients whose aortic root anatomy and lesions are not suitable for artificial valve implantation;
- Compound aortic valve disease (aortic stenosis with severe regurgitation); Severe mitral regurgitation;
- Hematological malignancies, hemophilia and other coagulation disorders;
- Hemodynamic instability, requiring mechanical cardiac assistance;
- Emergency operation for any reason;
- Obstructive hypertrophic cardiomyopathy;
- Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \< 30%;
- Severe right ventricular dysfunction;
- Echocardiography showed the presence of intracardiac mass, thrombus or vegetations;
- Active peptic ulcer or upper gastrointestinal hemorrhage within 3 months;
- Allergic to nickel titanium alloy, stainless steel alloy, PU (polyurethane), or contrast agent; Unable to tolerate anticoagulant and antiplatelet therapy;
- Cerebrovascular events (CVA) occurred within 3 months, including ischemic stroke and hemorrhagic stroke, excluding transient ischemic attack (TIA);
- Vascular diseases affecting the instrument approach;
- Infective endocarditis in active phase or other active infections;
- Those who have participated in clinical trials of other drugs or medical devices before enrollment and have not reached the time limit of the main research endpoint.
Key Trial Info
Start Date :
July 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05391191
Start Date
July 6 2022
End Date
March 31 2023
Last Update
July 12 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Zhongshan Hopital of Fudan University
Shanghai, Shanghai Municipality, China, 200032