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Clinical Trial in China for Aortic Valve Stenosis

Primary Purpose

Diseases of Aortic Valve, Aortic Stenosis Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcatheter aortic valve replacement
Sponsored by
Genesis Medtech Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diseases of Aortic Valve

Eligibility Criteria

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

Inclusion Criteria: Age ≥ 65; Patients with symptomatic aortic valve regurgitation diseases, and New York Heart Association (NYHA) ≥ II; Subject must have Society of Thoracic Surgeons (STS) score ≥8% or have been evaluated as inoperable by the surgical team [defined as rate of death #50% within 30 d post-surgery or accompanied with irreversible occasions of other factors prevent surgeries (such as heavily calcified (porcelain) ascending aorta, weakness, chest malformation, liver dysfunction, pulmonary dysfunction and so on ); (Note: age of inoperable patients can be expanded to ≥ 50); Aortic valve anatomy is suitable for TAVR evaluated by the investigators; Patients who can sign informed consent form, and are willing to accept relevant examinations and clinical follow-ups. Exclusion Criteria: Active endocarditis; Acute myocardial infarction or coronary revascularization occurred within 1 month before procedure; Cerebrovascular accident (CVA) occurred within 30 days before procedure; The echocardiogram indicates the presence of mass, thrombus or vegetation in left ventricle and left atrium; Hypertrophic obstructive cardiomyopathy; Other valve diseases that need interventions; Previous aortic valve implantation (mechanical or biological); Allergic to Nickel-titanium alloys or contrast agents or cattle-originated products; Known allergy or contraindication to all anticoagulation, or anticoagulation can not be used during the TAVR; In presence one of the following (from selection to the day of procedure index): a other diseases that may shorten life expectancy to less than 12 months (recurrent or metastatic cancer, congestive heart failure); b drug abuse (such as cocaine, heroin and so on); c planned additional operations that may result in incompliance or data confusion; Stenosis of common carotid artery, internal carotid artery or vertebral artery #70%; Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%; Hepatic encephalopathy or acute active hepatitis; Receiving hemodialysis; Bleeding tendency or history of coagulopathy or refuse to receive transfusion; Active gastrointestinal (GI) ulcer or bleeding; Severe dementia; Patients who need emergency surgery for any reason; Patients are participating in other drugs or medical devices clinical trial; Pregnant or plan to be pregnant, or are taking estrogen or estrogen-like drugs (Women suspected of pregnancy must have a negative serum or urine test for human villous gonadotropin prior to enrollment in the study); Other inappropriate occasions according to the investigators.

Sites / Locations

  • Beijing Anzhen Hospital,Capital Medical UniversityRecruiting
  • Chinese PLA General HoapitalRecruiting
  • Peking University Third HospitalRecruiting
  • Xuanwu Hospital Capital Medical UniversityRecruiting
  • Xinqiao Hospital Army Medical Univer SityRecruiting
  • Guangdong Academy of Medical SciencesRecruiting
  • Nanjing Drum Tower HospitalRecruiting
  • Zhongshan HospitalRecruiting
  • WEST CHINA hospitalRecruiting
  • The First Affiliated of Soochow UniversityRecruiting
  • Xijing Hospital of the Fourth Military Medical UniversityRecruiting
  • Xiamen Cardiovascular Hospital Xiamen UniversityRecruiting
  • Fuwai Yunnan Cardiovascular HospitalRecruiting
  • The Second Affiliated Hospital of Zhejiang UniversityRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: Treatment

Arm Description

Device: J-Valve® valve delivery system, Transvascularized biological aortic valve system

Outcomes

Primary Outcome Measures

Cumulative all-cause mortality
All-cause mortality within 12 months of TAVR procedure

Secondary Outcome Measures

Device success
No operative death;The instrument was placed in the correct anatomical position, and the delivery assembly was successfully entered and withdrawn;No device-related surgical or interventional intervention (other than permanent pacemaker implantation)
Procedural success
Technical success,No death,No device-related surgical or interventional intervention (except permanent pacemaker implantation),The artificial aortic valve achieved the expected value (mean transaortic pressure difference < 20mmHg or transaortic flow velocity < 3m/s; No moderate or greater artificial aortic regurgitation or perivalvular leakage)
Evaluation of bioprosthetic valve and cardiac function Evaluation of bioprosthetic valve and cardiac function Evaluation of bioprosthetic valve and cardiac function
Echocardiography was used to evaluate aortic valve function and cardiac function
Functional Improvement of heart ( NYHA)
NYHA classification of cardiac function was evaluated after operation
Quality of life(KCCQ)
Evaluation of postoperative Quality of life score improvement (KCCQ)
Major cardiovascular and cerebrovascular adverse events (MACCE)
Major adverse cardiovascular and cerebrovascular events (MACCE) included mortality, stroke, myocardial infarction, reoperation, arrhythmia, and conduction block.
Myocardial infarction
Incidence of myocardial infarction
Stroke
Grades include ischemic stroke (including transient ischemic attack, TIA) and hemorrhagic stroke Grades included ischemic stroke (including transient ischemic attack, TIA) and hemorrhagic stroke; Definitions included disabling stroke (modified Rankin score ≥2 at 90 days after stroke with an increase of >1 point) and nondisabling stroke (modified Rankin score <2 at 90 days after stroke with no increase in score). Stroke events should be recorded and the causes analyzed in detail.
Major bleeding (life-threatening or crippling)
Severe bleeding: BARC bleeding was defined as type 3a and above
Acute kidney injury
The incidence of AKIN stage 2 and above events was recorded.
Conduction block and malignant arrhythmia
The incidence of conduction block and malignant arrhythmias
Permanent pacemaker implantation
Permanent pacemaker implantation rate
TAVI related complications
These include conversion to surgery, accidental mechanical cardiopulmonary assistance, coronary occlusion, ventricular septal perforation, mitral valve damage or loss of function, cardiac tamponade, endocarditis, valve thrombosis, valve ectopic (displacement, embolization, misrelease), aortic dissection, aortic root rupture, and peripheral vascular complications.
Device defects
Incidence of device defects
The incidence of adverse events The incidence of adverse events
Incidence of adverse events
The incidence of serious adverse events
Incidence of serious adverse events

Full Information

First Posted
October 27, 2022
Last Updated
November 1, 2022
Sponsor
Genesis Medtech Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05607667
Brief Title
Clinical Trial in China for Aortic Valve Stenosis
Official Title
Efficacy and Safety of the J-Valve Transcatheter Aortic Valve Replacement System in Patients With Aortic Stenosis Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2022 (Anticipated)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genesis Medtech Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis disease who are at high or prohibitive surgical risk.
Detailed Description
This study is a prospective, multicenter, single-arm, clinical study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diseases of Aortic Valve, Aortic Stenosis Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Treatment
Arm Type
Experimental
Arm Description
Device: J-Valve® valve delivery system, Transvascularized biological aortic valve system
Intervention Type
Device
Intervention Name(s)
Transcatheter aortic valve replacement
Intervention Description
Transcatheter aortic valve replacement system
Primary Outcome Measure Information:
Title
Cumulative all-cause mortality
Description
All-cause mortality within 12 months of TAVR procedure
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Device success
Description
No operative death;The instrument was placed in the correct anatomical position, and the delivery assembly was successfully entered and withdrawn;No device-related surgical or interventional intervention (other than permanent pacemaker implantation)
Time Frame
30 days
Title
Procedural success
Description
Technical success,No death,No device-related surgical or interventional intervention (except permanent pacemaker implantation),The artificial aortic valve achieved the expected value (mean transaortic pressure difference < 20mmHg or transaortic flow velocity < 3m/s; No moderate or greater artificial aortic regurgitation or perivalvular leakage)
Time Frame
: immediate post-surgical
Title
Evaluation of bioprosthetic valve and cardiac function Evaluation of bioprosthetic valve and cardiac function Evaluation of bioprosthetic valve and cardiac function
Description
Echocardiography was used to evaluate aortic valve function and cardiac function
Time Frame
30 days, 6 months, 12 months
Title
Functional Improvement of heart ( NYHA)
Description
NYHA classification of cardiac function was evaluated after operation
Time Frame
30 days, 6 months, 12 months
Title
Quality of life(KCCQ)
Description
Evaluation of postoperative Quality of life score improvement (KCCQ)
Time Frame
30 days, 6 months, 12 months
Title
Major cardiovascular and cerebrovascular adverse events (MACCE)
Description
Major adverse cardiovascular and cerebrovascular events (MACCE) included mortality, stroke, myocardial infarction, reoperation, arrhythmia, and conduction block.
Time Frame
before discharge/7days, 30 days, 6 months, 12 months
Title
Myocardial infarction
Description
Incidence of myocardial infarction
Time Frame
before discharge/7days, 30 days, 6 months, 12 months
Title
Stroke
Description
Grades include ischemic stroke (including transient ischemic attack, TIA) and hemorrhagic stroke Grades included ischemic stroke (including transient ischemic attack, TIA) and hemorrhagic stroke; Definitions included disabling stroke (modified Rankin score ≥2 at 90 days after stroke with an increase of >1 point) and nondisabling stroke (modified Rankin score <2 at 90 days after stroke with no increase in score). Stroke events should be recorded and the causes analyzed in detail.
Time Frame
before discharge/7days, 30 days, 6 months, 12 months
Title
Major bleeding (life-threatening or crippling)
Description
Severe bleeding: BARC bleeding was defined as type 3a and above
Time Frame
before discharge/7days, 30 days, 6 months, 12 months
Title
Acute kidney injury
Description
The incidence of AKIN stage 2 and above events was recorded.
Time Frame
before discharge/7days, 30 days, 6 months, 12 months
Title
Conduction block and malignant arrhythmia
Description
The incidence of conduction block and malignant arrhythmias
Time Frame
before discharge/7days, 30 days, 6 months, 12 months
Title
Permanent pacemaker implantation
Description
Permanent pacemaker implantation rate
Time Frame
before discharge/7days, 30 days, 6 months, 12 months
Title
TAVI related complications
Description
These include conversion to surgery, accidental mechanical cardiopulmonary assistance, coronary occlusion, ventricular septal perforation, mitral valve damage or loss of function, cardiac tamponade, endocarditis, valve thrombosis, valve ectopic (displacement, embolization, misrelease), aortic dissection, aortic root rupture, and peripheral vascular complications.
Time Frame
before discharge/7days, 30 days, 6 months, 12 months
Title
Device defects
Description
Incidence of device defects
Time Frame
intraoperative
Title
The incidence of adverse events The incidence of adverse events
Description
Incidence of adverse events
Time Frame
12 months
Title
The incidence of serious adverse events
Description
Incidence of serious adverse events
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 65; Patients with symptomatic aortic valve regurgitation diseases, and New York Heart Association (NYHA) ≥ II; Subject must have Society of Thoracic Surgeons (STS) score ≥8% or have been evaluated as inoperable by the surgical team [defined as rate of death #50% within 30 d post-surgery or accompanied with irreversible occasions of other factors prevent surgeries (such as heavily calcified (porcelain) ascending aorta, weakness, chest malformation, liver dysfunction, pulmonary dysfunction and so on ); (Note: age of inoperable patients can be expanded to ≥ 50); Aortic valve anatomy is suitable for TAVR evaluated by the investigators; Patients who can sign informed consent form, and are willing to accept relevant examinations and clinical follow-ups. Exclusion Criteria: Active endocarditis; Acute myocardial infarction or coronary revascularization occurred within 1 month before procedure; Cerebrovascular accident (CVA) occurred within 30 days before procedure; The echocardiogram indicates the presence of mass, thrombus or vegetation in left ventricle and left atrium; Hypertrophic obstructive cardiomyopathy; Other valve diseases that need interventions; Previous aortic valve implantation (mechanical or biological); Allergic to Nickel-titanium alloys or contrast agents or cattle-originated products; Known allergy or contraindication to all anticoagulation, or anticoagulation can not be used during the TAVR; In presence one of the following (from selection to the day of procedure index): a other diseases that may shorten life expectancy to less than 12 months (recurrent or metastatic cancer, congestive heart failure); b drug abuse (such as cocaine, heroin and so on); c planned additional operations that may result in incompliance or data confusion; Stenosis of common carotid artery, internal carotid artery or vertebral artery #70%; Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%; Hepatic encephalopathy or acute active hepatitis; Receiving hemodialysis; Bleeding tendency or history of coagulopathy or refuse to receive transfusion; Active gastrointestinal (GI) ulcer or bleeding; Severe dementia; Patients who need emergency surgery for any reason; Patients are participating in other drugs or medical devices clinical trial; Pregnant or plan to be pregnant, or are taking estrogen or estrogen-like drugs (Women suspected of pregnancy must have a negative serum or urine test for human villous gonadotropin prior to enrollment in the study); Other inappropriate occasions according to the investigators.
Facility Information:
Facility Name
Beijing Anzhen Hospital,Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yujie Zhou, Doctor
Phone
010-64412431
Email
jyjb@cueb.edu.cn
Facility Name
Chinese PLA General Hoapital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yundai Chen, Doctor
Phone
010-68182255
Email
jfjzyygw@163.com
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yida Tang, Doctor
Phone
010-82266699
Email
bysy@bjmu.edu.cn
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunlin Yin, Doctor
Phone
010-83922345
Email
xuanwuhospital@sina.com
Facility Name
Xinqiao Hospital Army Medical Univer Sity
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingbin Xiao, Doctor
Phone
023-68755114
Email
xinqiao@mail.xqhospital.com.cn
Facility Name
Guangdong Academy of Medical Sciences
City
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huiming Guo, Doctor
Phone
020-83827812
Email
guohuiming@gdph.org.cn
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongjin Wang, Doctor
Phone
025-83106666
Email
glyyxfb@163.com
Facility Name
Zhongshan Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunsheng Wang, Doctor
Phone
021-64041990
Email
ec@zs-hospital.sh.cn
Facility Name
WEST CHINA hospital
City
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingqiang Guo, Doctor
Phone
028-85422114
Email
hxtfyyhfb@163.com
Facility Name
The First Affiliated of Soochow University
City
Suzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenya Shen, Doctor
Phone
0512-65223637
Email
sdfyyycgcc@163.com
Facility Name
Xijing Hospital of the Fourth Military Medical University
City
Xi'an
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Liu, Doctor
Phone
029-84775507
Email
xjyyyb@fmmu.edu.cn
Facility Name
Xiamen Cardiovascular Hospital Xiamen University
City
Xiamen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Wang, Doctor
Phone
0592-2292999
Email
xmhchr@126.com
Facility Name
Fuwai Yunnan Cardiovascular Hospital
City
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangbin Pan, Doctor
Phone
0871-65199777
Email
ynfwzhb@163.com
Facility Name
The Second Affiliated Hospital of Zhejiang University
City
Zhangjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianan Wang, Doctor
Phone
0571-87783777
Email
zrrs1@zju.edu.cn
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deguang Feng, Doctor
Phone
0371-66913114
Email
Yuanban3031@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Trial in China for Aortic Valve Stenosis

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