Clinical Trial in China for Aortic Valve Stenosis

NCT05607667 | Completed

• 1 other identifier: S202112-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 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 stenosis disease who are at high or prohibitive surgical risk.

Conditions

Diseases of Aortic Valve; Aortic Stenosis Disease

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 Evaluation of bioprosthetic valve and cardiac function 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

Study Arms (1)

Experimental: Treatment

EXPERIMENTAL

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

Device: Transcatheter aortic valve replacement

Interventions

Transcatheter aortic valve replacement DEVICE

Transcatheter aortic valve replacement system

Experimental: Treatment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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;
• Bleeding tendency or history of coagulopathy or refuse to receive transfusion;

Sponsors & Collaborators

• Genesis Medtech Corporation: lead

Study Sites (15)

Beijing Anzhen Hospital,Capital Medical University

Beijing, China

Location

Chinese PLA General Hoapital

Beijing, China

Location

Peking University Third Hospital

Beijing, China

Location

Xuanwu Hospital Capital Medical University

Beijing, China

Location

Xinqiao Hospital Army Medical Univer Sity

Chongqing, China

Location

Guangdong Academy of Medical Sciences

Guangdong, China

Location

Nanjing Drum Tower Hospital

Nanjing, China

Location

Zhongshan Hospital

Shanghai, China

Location

WEST CHINA hospital

Sichuan, China

Location

The First Affiliated of Soochow University

Suzhou, China

Location

Xijing Hospital of the Fourth Military Medical University

Xi'an, China

Location

Xiamen Cardiovascular Hospital Xiamen University

Xiamen, China

Location

Fuwai Yunnan Cardiovascular Hospital

Yunnan, China

Location

The Second Affiliated Hospital of Zhejiang University

Zhangjiang, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

MeSH Terms

Conditions

Aortic Valve Disease

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

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 27, 2022
• First Posted: November 7, 2022
• Study Start: October 14, 2022
• Primary Completion: July 3, 2024
• Study Completion: July 3, 2024
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)