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

Primary Purpose

Aortic Valve Stenosis

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Transcatheter Aortic Valve System

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥70 years old;
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.
NYHA Functional Class ≥II;
Life expectancy after aortic valve implantation thought to be >1 year;
Native valvular or peripheral vascular anatomy is appropriate for TAVR;
Patient is assessed by at least two cardiothoracic surgeons and recorded as not suitable for surgery;
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:

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);
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);
Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization);
Pre-existing prosthetic valve in any position(except severely dysfunctional aortic bioprosthesis), or severe (>3+) mitral insufficiency, or Gorlin syndrome;
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;
Hemodynamic unstable requiring myocardial contractile support or mechanical cardiac assistance;
Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) <20%;
Echocardiographic evidence of intra-cardiac thrombus or vegetation etc.;
Active pepticulcer or upper GI bleeding within 3 months prior to the study procedure;
Cerebral Vascular Accident (CVA) within 3 months prior to the study procedure, including TIA;
A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, or sensitivity to contrast media, which cannot be adequately pre-medicated;
Patients with infective endocarditis or other active stage of infection;
Currently participating in an investigational drug or another device trial.

Sites / Locations

Fuwai Hospital, CAMS&PUMCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Severe Aortic Valve Stenosis

Arm Description

Patients will be treated with Transcatheter Aortic Valve Systerm

Outcomes

Primary Outcome Measures

Rate of All-cause Mortality

Percentage of subjects who died from all causes in this population.

Secondary Outcome Measures

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)

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.

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.

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.

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.

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

Quality of Life Assessment

SF-12

NYHA function

Rate of All-cause Mortality

Incidence of Myocardial Infarction

Incidence of MACCE(including mortality, stroke, MI, re-procedure, Conduction disturbances and cardiac arrhythmias)

Incidence of Bleeding (life-threatening or disabling and major)

Incidence of Stroke

Incidence of AKI (stage 2 and 3,or renal replacement therapy (RRT: Hemodialysis, abdomen Cavity dialysis, hemofiltration))

Incidence of Permanent Pacemaker Implantation

Incidence of major vascular complications

Incidence of Conduction disturbances and cardiac arrhythmias

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

Full Information

NCT ID

NCT04893603

First Posted

April 28, 2021

Last Updated

May 17, 2021

Sponsor

Chengdu Silara Meditech Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04893603

Brief Title

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

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Recruiting

Study Start Date

December 16, 2020 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chengdu Silara Meditech Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Severe Aortic Valve Stenosis

Arm Type

Experimental

Arm Description

Patients will be treated with Transcatheter Aortic Valve Systerm

Intervention Type

Device

Intervention Name(s)

Transcatheter Aortic Valve System

Intervention Description

Procedure: Transcatheter aortic valve replacement

Primary Outcome Measure Information:

Title

Rate of All-cause Mortality

Description

Percentage of subjects who died from all causes in this population.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Rate of Device Success

Description

Time Frame

Immediate post- procedure

Title

Rate of Procedure Success

Description

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.

Time Frame

Immediate post- procedure

Title

Delivery System Performance

Description

Delivery System Performance wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor.

Time Frame

Immediate post- procedure

Title

Retrieval System Performance(if using)

Description

Retrieval System Performance wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor.

Time Frame

Immediate post- procedure

Title

Exchange Systerm Evaluation

Description

Exchange Systerm Evaluation wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor.

Time Frame

Immediate post- procedure

Title

Valvular function evaluation, including valve stenosis, AR, valve function(e.g. EOA, gradient) and PVL

Description

The evaluation criteria refer to the 2012 edition of the Association for Valvular Academic Research (VARC-2) consensus document

Time Frame

Immediate post-procedure, 7days or discharge, 30 days, 6 months ,12months and 2-5 years

Title

Quality of Life Assessment

Description

SF-12

Time Frame

30 days, 6 months,and 12 months

Title

NYHA function

Time Frame

7 days or discharge, 30 days, 6 months ,12 months and 2-5 years

Title

Rate of All-cause Mortality

Time Frame

Immediate post- procedure ,7 days /discharge, 30 days, 6 months and 2-5 years.

Title

Incidence of Myocardial Infarction

Time Frame

Immediate post- procedure, 7 days /discharge, 30 days, 6 months ,12months and 2-5 years.

Title

Incidence of MACCE(including mortality, stroke, MI, re-procedure, Conduction disturbances and cardiac arrhythmias)

Time Frame

Immediate post- procedure, 7 days /discharge, 30 days, 6 months,12months and 2-5 years.

Title

Incidence of Bleeding (life-threatening or disabling and major)

Time Frame

Immediate post- procedure, 7 days /discharge, 30 days, 6 months,12months and 2-5 years.

Title

Incidence of Stroke

Time Frame

7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.

Title

Incidence of AKI (stage 2 and 3,or renal replacement therapy (RRT: Hemodialysis, abdomen Cavity dialysis, hemofiltration))

Time Frame

7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.

Title

Incidence of Permanent Pacemaker Implantation

Time Frame

7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.

Title

Incidence of major vascular complications

Time Frame

Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months.

Title

Incidence of Conduction disturbances and cardiac arrhythmias

Time Frame

Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month and 2-5years

Title

Incidence of Other TAVI-related Complications

Description

Time Frame

Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month and 2-5years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥70 years old; 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. NYHA Functional Class ≥II; Life expectancy after aortic valve implantation thought to be >1 year; Native valvular or peripheral vascular anatomy is appropriate for TAVR; Patient is assessed by at least two cardiothoracic surgeons and recorded as not suitable for surgery; 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: 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); 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); Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization); Pre-existing prosthetic valve in any position(except severely dysfunctional aortic bioprosthesis), or severe (>3+) mitral insufficiency, or Gorlin syndrome; 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; Hemodynamic unstable requiring myocardial contractile support or mechanical cardiac assistance; Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) <20%; Echocardiographic evidence of intra-cardiac thrombus or vegetation etc.; Active pepticulcer or upper GI bleeding within 3 months prior to the study procedure; Cerebral Vascular Accident (CVA) within 3 months prior to the study procedure, including TIA; A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, or sensitivity to contrast media, which cannot be adequately pre-medicated; Patients with infective endocarditis or other active stage of infection; Currently participating in an investigational drug or another device trial.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Moyang Wang

Phone

(86)-010-68314466

wangmoyang1983@vip.sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yongjian Wu

Organizational Affiliation

Fuwai Hospital, CAMS & PUMC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fuwai Hospital, CAMS&PUMC

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yongjian Wu

First Name & Middle Initial & Last Name & Degree

Runlin Gao

First Name & Middle Initial & Last Name & Degree

Yongjian Wu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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