Clinical Trial in China for Aortic Valve Stenosis

Not Applicable

Recruiting

• Conditions: Aortic Stenosis Disease; Diseases of Aortic Valve
• Interventions: Device: Transcatheter aortic valve replacement

• Registration Number: NCT05607667
• Lead Sponsor: Genesis Medtech Corporation

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.

Study Timeline

• Study Start: 2022-10-27
• Study First Submitted: 2022-10-27
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-01
• Last Update Submitted: 2022-11-01
• Study First Posted: 2022-11-07
• Last Update Posted: 2022-11-07
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 53

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (15)

Chinese PLA General Hoapital; 🇨🇳 Beijing, China

Beijing Anzhen Hospital,Capital Medical University; 🇨🇳 Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, China

Xuanwu Hospital Capital Medical University; 🇨🇳 Beijing, China

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, China

Guangdong Academy of Medical Sciences; 🇨🇳 Guangdong, China

Xinqiao Hospital Army Medical Univer Sity; 🇨🇳 Chongqing, China

Zhongshan Hospital; 🇨🇳 Shanghai, China

WEST CHINA hospital; 🇨🇳 Sichuan, China

Xiamen Cardiovascular Hospital Xiamen University; 🇨🇳 Xiamen, China

The First Affiliated of Soochow University; 🇨🇳 Suzhou, China

Xijing Hospital of the Fourth Military Medical University; 🇨🇳 Xi'an, China

Fuwai Yunnan Cardiovascular Hospital; 🇨🇳 Yunnan, China

The Second Affiliated Hospital of Zhejiang University; 🇨🇳 Zhangjiang, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, China