A Prospective, Multicenter, Single-group Clinical Study to Evaluate the Safety and Efficacy of Peijia Medical Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Regurgitation

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To evaluate the safety and effectiveness of the TaurusTrio™ Heart Valve System in a patient population with symptomatic severe AR requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients who voluntarily participate and sign the informed consent and are able to comply with the entire trial process;

• Age ≥ 18 years;

• Adult subjects with severe AR (Grade ≥ 3) as assessed by echocardiography based on ASE (American Society of Echocardiography) using multiparametric approach with:

‣ Jet width ≥ 65% of LVOT

⁃ Vena contracta width of \> 6 mm

⁃ Holodiastolic flow reversal in proximal abdominal/descending aorta

⁃ Jet deceleration rate/Pressure half time \<200ms

⁃ AND, For Grade 3:

⁃ Regurgitant volume ≥ 45-59 ml/beat

⁃ Regurgitant fraction ≥ 40-49%

⁃ EROA ≥ 0.2-0.29 cm2

⁃ OR, For Grade 4:

⁃ Regurgitant volume ≥ 60 ml/beat

⁃ Regurgitant fraction≥50%

⁃ EROA ≥ 0.3 cm2 Note: In cases where not all criteria listed for severe AR are met, the Core Lab will determine severity. Supplemental CMR imaging may be used to substantiate the degree of AR reported by Core Lab on baseline echo when imaging is suboptimal, Doppler parameters are discordant or inconclusive regarding the severity of AR, or when a discrepancy is present between the echo findings and the clinical setting.

• Patients who have symptoms obviously caused by Aortic Regurgitation, such as dyspnea, chest pain, NYHA Class II or higher;

• Patients who are unsuitable for conventional surgery but needs TAVR(It is recommended to refer to the 2020 ACC/AHA Heart Valve Disease Management Guidelines when evaluating the risks of surgical valve surgery),evaluated by the cardiac team (including at least one interventional cardiologist and one cardiovascular surgeon)

• Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy™ Heart Valve System,evaluated by core laboratory;

Locations
Other Locations
China
Beijing Anzhen Hospital
RECRUITING
Beijing
Fu Wai Hospital, Beijing, China
RECRUITING
Beijing
Second Xiangya Hospital of Central South University
RECRUITING
Changsha
West China Hospital
RECRUITING
Chengdu
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Nanfang Hospital, Southern Medical University
RECRUITING
Guangdong
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
The Second Affiliated Hospital of Harbin Medical University
RECRUITING
Haerbin
Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
Sir Run Run Shaw Hospital of Zhejiang
RECRUITING
Hangzhou
Qilu Hospital of Shandong University
RECRUITING
Jinan
The First Affiliated Hospital of Namchang Umiversity
RECRUITING
Nanchang
Nanjing First Hospital
RECRUITING
Nanjing
Shanghai Zhongshan Hospital
RECRUITING
Shanghai
General Hospital of Northern Theater Command
RECRUITING
Shenyang
Renmin Hospital of Wuhan University
RECRUITING
Wuhan
Wuhan Union Hospital, China
RECRUITING
Wuhan
XiaMen Cardiovascular Hospital XiaMen University
RECRUITING
Xiamen
Xijing Hospital
RECRUITING
Xian
Contact Information
Primary
jing ren
renjing@peijiamedical.com
18550112597
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2029-07-31
Participants
Target number of participants: 116
Treatments
Experimental: A single set of test
The experimental apparatus consisted of TaurusTrio™ Heart Valve (THV), Delivery Catheter \& Introducer Sheath ,Loading Tools
Related Therapeutic Areas
Sponsors
Leads: Peijia Medical Technology (Suzhou) Co., Ltd.

This content was sourced from clinicaltrials.gov