To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis

Aortic Valve Stenosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04893603
• Other study ID #: Silara201901
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2021
• Source: Chengdu Silara Meditech Inc.
• Contact: Moyang Wang
• Phone: (86)-010-68314466
• Email: wangmoyang1983[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• Transcatheter Aortic Valve System
Procedure: Transcatheter aortic valve replacement

Locations

Country	Name	City	State
China	Fuwai Hospital, CAMS&PUMC	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu Silara Meditech Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of All-cause Mortality	Percentage of subjects who died from all causes in this population.	12 months
Secondary	Rate of Device Success	Device Success is defined as a composite of : Absence of procedural mortality AND; Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system AND; Correct positioning of prosthetic heart valve into the proper anatomical location AND; Intended performance of the prosthetic heart valve (mean aortic valve gradient<20 mmHg or peak velocity<3 m/s, and no severe prosthetic valve regurgitation or PVL)	Immediate post- procedure
Secondary	Rate of Procedure Success	Procedure Success is defined as no death, stroke, myocardial infarction and renal failure occurred within 72 hours after the operation on the basis of the final device success.	Immediate post- procedure
Secondary	Delivery System Performance	Delivery System Performance wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor.	Immediate post- procedure
Secondary	Retrieval System Performance(if using)	Retrieval System Performance wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor.	Immediate post- procedure
Secondary	Exchange Systerm Evaluation	Exchange Systerm Evaluation wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor.	Immediate post- procedure
Secondary	Valvular function evaluation, including valve stenosis, AR, valve function(e.g. EOA, gradient) and PVL	The evaluation criteria refer to the 2012 edition of the Association for Valvular Academic Research (VARC-2) consensus document	Immediate post-procedure, 7days or discharge, 30 days, 6 months ,12months and 2-5 years
Secondary	Quality of Life Assessment	SF-12	30 days, 6 months,and 12 months
Secondary	NYHA function		7 days or discharge, 30 days, 6 months ,12 months and 2-5 years
Secondary	Rate of All-cause Mortality		Immediate post- procedure ,7 days /discharge, 30 days, 6 months and 2-5 years.
Secondary	Incidence of Myocardial Infarction		Immediate post- procedure, 7 days /discharge, 30 days, 6 months ,12months and 2-5 years.
Secondary	Incidence of MACCE(including mortality, stroke, MI, re-procedure, Conduction disturbances and cardiac arrhythmias)		Immediate post- procedure, 7 days /discharge, 30 days, 6 months,12months and 2-5 years.
Secondary	Incidence of Bleeding (life-threatening or disabling and major)		Immediate post- procedure, 7 days /discharge, 30 days, 6 months,12months and 2-5 years.
Secondary	Incidence of Stroke		7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.
Secondary	Incidence of AKI (stage 2 and 3,or renal replacement therapy (RRT: Hemodialysis, abdomen Cavity dialysis, hemofiltration))		7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.
Secondary	Incidence of Permanent Pacemaker Implantation		7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.
Secondary	Incidence of major vascular complications		Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months.
Secondary	Incidence of Conduction disturbances and cardiac arrhythmias		Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month and 2-5years
Secondary	Incidence of Other TAVI-related Complications	including transfer to surgery , Accidental heart-lung machine, coronary obstruction, ventricular septal rupture, Mitral valve damage or dysfunction,cardiac tamponade,endocarditis ,valvular thrombus,Valve migration(shifting, detachment,embolism,error deployment),valve in valve	Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month and 2-5years