Clinical Trial in China for Aortic Valve Stenosis

Efficacy and Safety of the J-Valve Transcatheter Aortic Valve Replacement System in Patients With Aortic Stenosis Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Diseases of Aortic Valve; Aortic Stenosis Disease
• Intervention / Treatment: Device: Transcatheter aortic valve replacement

Detailed Description

This study is a prospective, multicenter, single-arm, clinical study.

• Study Type: Interventional
• Enrollment (Anticipated): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Xuanwu Hospital Capital Medical University
    • Contact: Chunlin Yin, Doctor; Phone Number: 010-83922345; Email: xuanwuhospital@sina.com
  • Beijing, China
    • Recruiting
    • Peking University Third Hospital
    • Contact: Yida Tang, Doctor; Phone Number: 010-82266699; Email: bysy@bjmu.edu.cn
  • Beijing, China
    • Recruiting
    • Beijing Anzhen Hospital，Capital Medical University
    • Contact: Yujie Zhou, Doctor; Phone Number: 010-64412431; Email: jyjb@cueb.edu.cn
  • Beijing, China
    • Recruiting
    • Chinese PLA General Hoapital
    • Contact: Yundai Chen, Doctor; Phone Number: 010-68182255; Email: jfjzyygw@163.com
  • Chongqing, China
    • Recruiting
    • Xinqiao Hospital Army Medical Univer Sity
    • Contact: Yingbin Xiao, Doctor; Phone Number: 023-68755114; Email: xinqiao@mail.xqhospital.com.cn
  • Guangdong, China
    • Recruiting
    • Guangdong Academy of Medical Sciences
    • Contact: Huiming Guo, Doctor; Phone Number: 020-83827812; Email: guohuiming@gdph.org.cn
  • Nanjing, China
    • Recruiting
    • Nanjing Drum Tower hospital
    • Contact: Dongjin Wang, Doctor; Phone Number: 025-83106666; Email: glyyxfb@163.com
  • Shanghai, China
    • Recruiting
    • Zhongshan Hospital
    • Contact: Chunsheng Wang, Doctor; Phone Number: 021-64041990; Email: ec@zs-hospital.sh.cn
  • Sichuan, China
    • Recruiting
    • West China Hospital
    • Contact: Yingqiang Guo, Doctor; Phone Number: 028-85422114; Email: hxtfyyhfb@163.com
  • Suzhou, China
    • Recruiting
    • The First Affiliated of Soochow University
    • Contact: Zhenya Shen, Doctor; Phone Number: 0512-65223637; Email: sdfyyycgcc@163.com
  • Xi'an, China
    • Recruiting
    • Xijing Hospital of the Fourth Military Medical University
    • Contact: Yang Liu, Doctor; Phone Number: 029-84775507; Email: xjyyyb@fmmu.edu.cn
  • Xiamen, China
    • Recruiting
    • Xiamen Cardiovascular Hospital Xiamen University
    • Contact: Yan Wang, Doctor; Phone Number: 0592-2292999; Email: xmhchr@126.com
  • Yunnan, China
    • Recruiting
    • Fuwai Yunnan Cardiovascular Hospital
    • Contact: Xiangbin Pan, Doctor; Phone Number: 0871-65199777; Email: ynfwzhb@163.com
  • Zhangjiang, China
    • Recruiting
    • The Second Affiliated Hospital of Zhejiang University
    • Contact: Jianan Wang, Doctor; Phone Number: 0571-87783777; Email: zrrs1@zju.edu.cn
  • Zhengzhou, China
    • Recruiting
    • The First Affiliated Hospital of Zhengzhou University
    • Contact: Deguang Feng, Doctor; Phone Number: 0371-66913114; Email: Yuanban3031@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥ 65;
2. Patients with symptomatic aortic valve regurgitation diseases, and New York Heart Association (NYHA) ≥ II;
3. 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);
4. Aortic valve anatomy is suitable for TAVR evaluated by the investigators;
5. Patients who can sign informed consent form, and are willing to accept relevant examinations and clinical follow-ups.

Exclusion Criteria:

1. Active endocarditis;
2. Acute myocardial infarction or coronary revascularization occurred within 1 month before procedure;
3. Cerebrovascular accident (CVA) occurred within 30 days before procedure;
4. The echocardiogram indicates the presence of mass, thrombus or vegetation in left ventricle and left atrium;
5. Hypertrophic obstructive cardiomyopathy;
6. Other valve diseases that need interventions;
7. Previous aortic valve implantation (mechanical or biological);
8. Allergic to Nickel-titanium alloys or contrast agents or cattle-originated products;
9. Known allergy or contraindication to all anticoagulation, or anticoagulation can not be used during the TAVR;
10. 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;
11. Stenosis of common carotid artery, internal carotid artery or vertebral artery #70%;
12. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%;
13. Hepatic encephalopathy or acute active hepatitis;
14. Receiving hemodialysis;
15. Bleeding tendency or history of coagulopathy or refuse to receive transfusion;
16. Active gastrointestinal (GI) ulcer or bleeding;
17. Severe dementia;
18. Patients who need emergency surgery for any reason;
19. Patients are participating in other drugs or medical devices clinical trial;
20. 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);
21. Other inappropriate occasions according to the investigators.

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: Experimental: Treatment; Device: J-Valve® valve delivery system， Transvascularized biological aortic valve system	Device: Transcatheter aortic valve replacement; Transcatheter aortic valve replacement system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative all-cause mortality	All-cause mortality within 12 months of TAVR procedure	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Improvement of heart ( NYHA）	NYHA classification of cardiac function was evaluated after operation	30 days, 6 months, 12 months
Quality of life（KCCQ）	Evaluation of postoperative Quality of life score improvement (KCCQ)	30 days, 6 months, 12 months
Device defects	Incidence of device defects	intraoperative
The incidence of serious adverse events	Incidence of serious adverse events	12 months
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)	30 days
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)	: immediate post-surgical
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	30 days, 6 months, 12 months
Major cardiovascular and cerebrovascular adverse events (MACCE)	Major adverse cardiovascular and cerebrovascular events (MACCE) included mortality, stroke, myocardial infarction, reoperation, arrhythmia, and conduction block.	before discharge/7days, 30 days, 6 months, 12 months
Myocardial infarction	Incidence of myocardial infarction	before discharge/7days, 30 days, 6 months, 12 months
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.	before discharge/7days, 30 days, 6 months, 12 months
Major bleeding (life-threatening or crippling)	Severe bleeding: BARC bleeding was defined as type 3a and above	before discharge/7days, 30 days, 6 months, 12 months
Acute kidney injury	The incidence of AKIN stage 2 and above events was recorded.	before discharge/7days, 30 days, 6 months, 12 months
Conduction block and malignant arrhythmia	The incidence of conduction block and malignant arrhythmias	before discharge/7days, 30 days, 6 months, 12 months
Permanent pacemaker implantation	Permanent pacemaker implantation rate	before discharge/7days, 30 days, 6 months, 12 months
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.	before discharge/7days, 30 days, 6 months, 12 months
The incidence of adverse events The incidence of adverse events	Incidence of adverse events	12 months

Collaborators and Investigators

• Sponsor: Genesis Medtech Corporation

Study record dates

Study Major Dates

• Study Start (Anticipated): October 27, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic; Aortic Valve Disease
• Other Study ID Numbers: S202112-01

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