Clinical Trial in China
Efficacy and Safety of the J-Valve Transcatheter Aortic Valve Replacement System in Patients With Aortic Regurgitation Disease
1 other identifier
interventional
120
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2022
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2022
CompletedFirst Posted
Study publicly available on registry
October 14, 2022
CompletedStudy Start
First participant enrolled
October 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedOctober 14, 2022
October 1, 2022
7 months
October 10, 2022
October 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulative all-cause mortality
All-cause mortality within 12 months of TAVR procedure
12 months
Secondary Outcomes (16)
Device success
30 days
Procedural success
immediate post-surgical
Evaluation of bioprosthetic valve and cardiac function
30 days, 6 months, 12 months
Functional Improvement of heart ( NYHA）
30 days, 6 months, 12 months
Quality of life（KCCQ）
30 days, 6 months, 12 months
- +11 more secondary outcomes
Study Arms (1)
Experimental: Treatment
EXPERIMENTALDevice: J-Valve® valve delivery system
Interventions
Transcatheter aortic valve replacement system
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Beijing Anzhen Hospital,Capital Medical University
Beijing, China
Chinese PLA General Hoapital
Beijing, China
Peking University Third Hospital
Beijing, China
Xuanwu Hospital Capital Medical University
Beijing, China
Xinqiao Hospital Army Medical Univer Sity
Chongqing, China
Guangdong Academy of Medical Sciences
Guangdong, China
Nanjing Drum Tower Hospital
Nanjing, China
Zhongshan Hospital
Shanghai, China
WEST CHINA hospital
Sichuan, China
The First Affiliated of Soochow University
Suzhou, China
Xijing Hospital of the Fourth Military Medical University
Xi'an, China
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, China
Fuwai Yunnan Cardiovascular Hospital
Yunnan, China
The Second Affiliated Hospital of Zhejiang University
Zhejiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2022
First Posted
October 14, 2022
Study Start
October 14, 2022
Primary Completion
May 1, 2023
Study Completion
May 1, 2024
Last Updated
October 14, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share