Clinical trial NCT05580952: Clinical Trial in China
Official title: Efficacy and Safety of the J-Valve Transcatheter Aortic Valve Replacement System in Patients With Aortic Regurgitation Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diseases of Aortic Valve
Aortic Regurgitation Disease
Lead sponsor: Genesis Medtech Corporation
Sponsor class: INDUSTRY
First posted: 2022-10-14
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 regurgitation disease who are at high or prohibitive surgical risk.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative all-cause mortality
timeFrame: 12 months
Secondary outcomes:
measure: Device success
timeFrame: 30 days
measure: Procedural success
timeFrame: immediate post-surgical
measure: Evaluation of bioprosthetic valve and cardiac function
timeFrame: 30 days, 6 months, 12 months
measure: Functional Improvement of heart ( NYHA）
timeFrame: 30 days, 6 months, 12 months
measure: Quality of life（KCCQ）
timeFrame: 30 days, 6 months, 12 months
measure: Major cardiovascular and cerebrovascular adverse events (MACCE)
timeFrame: before discharge, 30 days, 6 months, 12 months
measure: Myocardial infarction
timeFrame: before discharge, 30 days, 6 months, 12 months
measure: Stroke
timeFrame: before discharge, 30 days, 6 months, 12 months
measure: Major bleeding (life-threatening or crippling)
timeFrame: before discharge, 30 days, 6 months, 12 months
measure: Acute kidney injury
timeFrame: before discharge, 30 days, 6 months, 12 months
measure: Conduction block and malignant arrhythmia
timeFrame: before discharge, 30 days, 6 months, 12 months
measure: Permanent pacemaker implantation
timeFrame: before discharge, 30 days, 6 months, 12 months
measure: TAVI related complications
timeFrame: before discharge, 30 days, 6 months, 12 months
measure: Device defects
timeFrame: intraoperative
measure: The incidence of adverse events
timeFrame: 12 months
measure: The incidence of serious adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital,Capital Medical University
city: Beijing
country: China
facility: Chinese PLA General Hoapital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
city: Chongqing
country: China
facility: Xinqiao Hospital Army Medical Univer Sity
city: Guangdong
country: China
facility: Guangdong Academy of Medical Sciences
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital
city: Sichuan
country: China
facility: WEST CHINA hospital
city: Suzhou
country: China
facility: The First Affiliated of Soochow University
city: Xi'an
country: China
facility: Xijing Hospital of the Fourth Military Medical University
city: Xiamen
country: China
facility: Xiamen Cardiovascular Hospital Xiamen University
city: Yunnan
country: China
facility: Fuwai Yunnan Cardiovascular Hospital
city: Zhejiang
country: China
facility: The Second Affiliated Hospital of Zhejiang University
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
References: