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

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

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

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Transcatheter Aortic Valve System

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moyang Wang; Phone Number: (86)-010-68314466; Email: wangmoyang1983@vip.sina.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Fuwai Hospital, CAMS&PUMC
    • Contact: yongjian Wu
    • Principal Investigator: Yongjian Wu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Severe Aortic Valve Stenosis; Patients will be treated with Transcatheter Aortic Valve Systerm	Device: Transcatheter Aortic Valve System; Procedure: Transcatheter aortic valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of All-cause Mortality	Percentage of subjects who died from all causes in this population.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Assessment	SF-12	30 days, 6 months,and 12 months
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
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
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
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
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
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
NYHA function		7 days or discharge, 30 days, 6 months ,12 months and 2-5 years
Rate of All-cause Mortality		Immediate post- procedure ,7 days /discharge, 30 days, 6 months and 2-5 years.
Incidence of Myocardial Infarction		Immediate post- procedure, 7 days /discharge, 30 days, 6 months ,12months and 2-5 years.
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.
Incidence of Bleeding (life-threatening or disabling and major)		Immediate post- procedure, 7 days /discharge, 30 days, 6 months,12months and 2-5 years.
Incidence of Stroke		7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.
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.
Incidence of Permanent Pacemaker Implantation		7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.
Incidence of major vascular complications		Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months.
Incidence of Conduction disturbances and cardiac arrhythmias		Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month and 2-5years
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

Collaborators and Investigators

• Sponsor: Chengdu Silara Meditech Inc.
• Investigators: Principal Investigator: Yongjian Wu, Fuwai Hospital, CAMS&PUMC

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: Silara201901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No