Clinical trial NCT04893603: To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis
Official title: A Prospective, Multi-center, Single-arm Clinical Trial to Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis With or Without Moderate or Lower Degree Regurgitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Lead sponsor: Chengdu Silara Meditech Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-19
Enrollment: 120
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Aortic Stenosis with or without Moderate or Lower Degree Regurgitation

Detailed description: Transcatheter Aortic Valve System (Chengdu Silara Medtech Inc. ,Chengdu, China) will be used for this study.

Eligibility criteria: Inclusion Criteria:

1. Age ≥70 years old;
2. Symptomatic severe aortic stenosis determined by echocardiogram, defined as: mean gradient ≥40 mmHg or peak jet velocity ≥4.0 m/s, or an aortic valve area \<0.8 cm2 or aortic valve area index \<0.5 cm2/m2.
3. NYHA Functional Class ≥II;
4. Life expectancy after aortic valve implantation thought to be \>1 year;
5. Native valvular or peripheral vascular anatomy is appropriate for TAVR;
6. Patient is assessed by at least two cardiothoracic surgeons and recorded as not suitable for surgery;
7. Patient can understand the purpose of the study, voluntarily participates and signs the informed consent form and is willing to accept the relevant examination and clinical follow-up visits.

Exclusion Criteria:

1. Anatomy is not appropriate for percutaneous valve implantation. Native valve annulus diameter is not in the scope of application(native TAV diameter ≤21mm, or ≥30mm);
2. Evidence of an acute myocardial infarction within 30 days prior to the study procedure, defined as: Q-wave myocardial infarction, or non-Q-wave myocardial infarction, with CK-MB≥2 ULN/or elevated TN (WHO definition);
3. Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization);
4. Pre-existing prosthetic valve in any position(except severely dysfunctional aortic bioprosthesis), or severe (\>3+) mitral insufficiency, or Gorlin syndrome;
5. Hematological abnormality, defined as: Leukopenia (WBC \<3x10\^9/L), acute anemia (Hb \<90g/L), or thrombocytopenia (platelet count\<50×109/L),history of bleeding diathesis or coagulopathy;
6. Hemodynamic unstable requiring myocardial contractile support or mechanical cardiac assistance;
7. Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) \<20%;
8. Echocardiographic evidence of intra-cardiac thrombus or vegetation etc.;
9. Active pepticulcer or upper GI bleeding within 3 months prior to the study procedure;
10. Cerebral Vascular Accident (CVA) within 3 months prior to the study procedure, including TIA;
11. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, or sensitivity to contrast media, which cannot be adequately pre-medicated;
12. Patients with infective endocarditis or other active stage of infection;
13. Currently participating in an investigational drug or another device trial.

Primary outcomes:
measure: Rate of All-cause Mortality
timeFrame: 12 months
Secondary outcomes:
measure: Rate of Device Success
timeFrame: Immediate post- procedure
measure: Rate of Procedure Success
timeFrame: Immediate post- procedure
measure: Delivery System Performance
timeFrame: Immediate post- procedure
measure: Retrieval System Performance(if using)
timeFrame: Immediate post- procedure
measure: Exchange Systerm Evaluation
timeFrame: Immediate post- procedure
measure: Valvular function evaluation, including valve stenosis, AR, valve function(e.g. EOA, gradient) and PVL
timeFrame: Immediate post-procedure, 7days or discharge, 30 days, 6 months ,12months and 2-5 years
measure: Quality of Life Assessment
timeFrame: 30 days, 6 months,and 12 months
measure: NYHA function
timeFrame: 7 days or discharge, 30 days, 6 months ,12 months and 2-5 years
measure: Rate of All-cause Mortality
timeFrame: Immediate post- procedure ,7 days /discharge, 30 days, 6 months and 2-5 years.
measure: Incidence of Myocardial Infarction
timeFrame: Immediate post- procedure, 7 days /discharge, 30 days, 6 months ,12months and 2-5 years.
measure: Incidence of MACCE(including mortality, stroke, MI, re-procedure, Conduction disturbances and cardiac arrhythmias)
timeFrame: Immediate post- procedure, 7 days /discharge, 30 days, 6 months,12months and 2-5 years.
measure: Incidence of Bleeding (life-threatening or disabling and major)
timeFrame: Immediate post- procedure, 7 days /discharge, 30 days, 6 months,12months and 2-5 years.
measure: Incidence of Stroke
timeFrame: 7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.
measure: Incidence of AKI (stage 2 and 3,or renal replacement therapy (RRT: Hemodialysis, abdomen Cavity dialysis, hemofiltration))
timeFrame: 7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.
measure: Incidence of Permanent Pacemaker Implantation
timeFrame: 7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.
measure: Incidence of major vascular complications
timeFrame: Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months.
measure: Incidence of Conduction disturbances and cardiac arrhythmias
timeFrame: Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month and 2-5years
measure: Incidence of Other TAVI-related Complications
timeFrame: Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month and 2-5years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, CAMS&PUMC
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Yongjian Wu
role: PRINCIPAL_INVESTIGATOR
References: