Safety and Effectiveness of TaurusTrio™ Heart Valve System in Patients With Severe Aortic Regurgitation (AR)
NCT ID: NCT06101888
Last Updated: 2024-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
116 participants
INTERVENTIONAL
2023-08-01
2029-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A single set of test
The experimental apparatus consisted of TaurusTrio™ Heart Valve (THV), Delivery Catheter \& Introducer Sheath ,Loading Tools
TaurusTrio™ Heart Valve System
The TaurusTrio™ Heart Valve System contains the following sub-components: a prosthetic transcatheter porcine pericardial aortic valve, 20Fr Introducer Sheath System, transfemoral Delivery Catheter, and Loading Tool.
Interventions
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TaurusTrio™ Heart Valve System
The TaurusTrio™ Heart Valve System contains the following sub-components: a prosthetic transcatheter porcine pericardial aortic valve, 20Fr Introducer Sheath System, transfemoral Delivery Catheter, and Loading Tool.
Eligibility Criteria
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Inclusion Criteria
* 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;
Exclusion Criteria
* Previous prosthetic aortic valve (bioprosthesis or mechanical) implant；
* Mitral regurgitation or Tricuspid regurgitation\> moderate；
* Clinically significant coronary artery disease (CAD) requiring revascularization within 30 days prior to index procedure, or planned CAD revascularization procedure within 12 months after index procedure；
* Echocardiographic evidence of left ventricular thrombus；
* Endocarditis within 180 days prior to index procedure；
* Hypertrophic cardiomyopathy with or without obstruction；
* Severe pulmonary hypertension (systolic PA pressure \>80 mmHg)；
* Severe RV dysfunction as assessed clinically and by echo；
* Severely reduced left ventricular ejection fraction (LVEF \<25%)；
* Aortic annular perimeter derived diameter of \<21.0 mm or \> 28.6 mm or perimeter \<66.0 mm or \>90 mm (assessed by Multi-Detector CT measurement)；
* Aortic annulus angulation \> 70° (assessed by Multi-Detector CT measurement)；
* Straight length of ascending aorta of \< 55 mm；
* Significant disease of ascending aorta, including ascending aortic aneurysm ； (defined as maximal luminal diameter of 50 mm or greater) or atheroma (including if thick \[\>5 mm\], protruding or ulcerated)
* Need for urgent or emergent TAVR procedure for any reason；
* Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device within 30 days prior to index procedure；
* Myocardial infarction \< 30 days prior to index procedure；
* Cerebrovascular event (TIA, stroke) \< 180 days prior to index procedure；
* Patients with common carotid artery or internal carotid artery or vertebral artery stenosis (\>70%)；
* Patients with severe coagulopathy；
* Severe renal insufficiency (GFR \< 30 ml/min) at Screening, OR renal disease requiring renal replacement therapy within 180 days prior to index procedure；
* Blood dyscrasias as defined: leukopenia (WBC \< 3000/mm³), or thrombocytopenia (platelets \< 90,000/µl) or anemia (Men: Hgb \< 8.1 g/dl; Women: Hgb \< 7.4 g/dl)；
* Active peptic ulcer or upper gastrointestinal bleeding \< 90 days prior to index procedure；
* Known allergies to to heparin, aspirin, ticlopidine, Clopidogrel, Nitroglycerin and other drugs，contrast agents, nitinol shape memory alloy, tantalum or porcine products；
* Contraindication to intraoperative transesophageal echocardiography and/or Multi-Detector CT (MDCT) scan；
* Estimated life-expectancy of \< 24 months；
* Patient is enrolled in another investigational medical device or drug study which has not completed the required primary endpoint follow-up. (Note: Patients involved in a long-term surveillance phase of another study are eligible for enrollment in this study);
* Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the patient from providing appropriate informed consent;
* Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments);
* Unable to comply with follow-up requirements;
18 Years
ALL
No
Sponsors
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Peijia Medical Technology (Suzhou) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Fu Wai Hospital, Beijing, China
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
XiaMen Cardiovascular Hospital XiaMen University
Xiamen, Fujian, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangdong, Guangzhou, China
The Second Affiliated Hospital of Harbin Medical University
Haerbin, Heilongjiang, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Wuhan Union Hospital, China
Wuhan, Hubei, China
Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing First Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Namchang Umiversity
Nanchang, Jiangxi, China
General Hospital of Northern Theater Command
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Xijing Hospital
Xian, Shanxi, China
West China Hospital
Chengdu, Sichuan, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital of Zhejiang
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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guangyuan Song
Role: primary
yongjian Wu
Role: primary
lianglong chen
Role: primary
liangwan chen
Role: backup
yan Wang
Role: primary
jianfang Luo
Role: primary
jiancheng Xiu
Role: primary
bo Yu
Role: primary
hong Jiang
Role: primary
xiang Cheng
Role: primary
shenghua Zhou
Role: primary
shaoliang Chen
Role: primary
xiaoping Peng
Role: primary
yaling Han
Role: primary
guipeng An
Role: primary
xinghua Gu
Role: backup
junbo Ge
Role: primary
jian Yang
Role: primary
mao chen
Role: primary
jianan Wang
Role: primary
guosheng Fu
Role: primary
Other Identifiers
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15CSP001
Identifier Type: -
Identifier Source: org_study_id
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