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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A single set of test | Experimental | The experimental apparatus consisted of TaurusTrio™ Heart Valve (THV), Delivery Catheter & Introducer Sheath ,Loading Tools |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TaurusTrio™ Heart Valve System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality at 12 months | All-cause mortality | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in quality of life (QoL) at 12 months over baseline, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). | Improvement in quality of life (QoL) | 12 months |
| Composite safety endpoint at 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success at exit from OR, hybrid room or cath lab post-index procedure | Absence of procedural mortality; and Successful access, delivery, and retrieval of transcatheter delivery system; and Deployment and correct positioning of a single intended THV; and Freedom from re-intervention related to the device or access procedure | Immediate after procedure |
Inclusion Criteria:
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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jing ren | Contact | 18550112597 | renjing@peijiamedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Recruiting | Beijing | Beijing Municipality | 215025 | China |
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all-cause death;all stroke; life-threatening or major bleeding;acute kidney injury (AKI) stage 2, 3 or dialysis;major vascular complications;surgery/intervention related to the device (including coronary intervention);permanent pacemaker implantation;moderate or severe total aortic regurgitation
| 30 days after procedure |
| Device Success at 1-month consisting of | Absence of procedure mortality; and Correct position of a single prosthetic heart valve Intended performance of the prosthetic heart valve (i.e., no prosthesis mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s; and no moderate or severe prosthetic valve regurgitation) Intended performance of the prosthetic heart valve (i.e., no prosthesis mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s; and no moderate or severe prosthetic valve regurgitation) | 30 days after procedure |
| Procedural Success at 1-month consisting of | Device success at 30 days; and No device- or procedure-related serious adverse events (defined as below): i) No disabling or non-disabling stroke ii) No life-threatening bleeding (>4 units PRBC) iii) No acute kidney injury - Stage 2 or 3 (including dialysis) iv) No major vascular complication v) No myocardial infarction or cardiac ischemia requiring PCI or CABG vi) No valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR) | 30 days after procedure |
| Fu Wai Hospital, Beijing, China | Recruiting | Beijing | Beijing Municipality | China |
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| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | China |
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| XiaMen Cardiovascular Hospital XiaMen University | Recruiting | Xiamen | Fujian | China |
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| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | China |
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| Nanfang Hospital, Southern Medical University | Recruiting | Guangdong | Guangzhou | China |
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| The Second Affiliated Hospital of Harbin Medical University | Recruiting | Haerbin | Heilongjiang | China |
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| Renmin Hospital of Wuhan University | Recruiting | Wuhan | Hubei | China |
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| Wuhan Union Hospital, China | Recruiting | Wuhan | Hubei | China |
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| Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
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| Nanjing First Hospital | Recruiting | Nanjing | Jiangsu | China |
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| The First Affiliated Hospital of Namchang Umiversity | Recruiting | Nanchang | Jiangxi | China |
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| General Hospital of Northern Theater Command | Recruiting | Shenyang | Liaoning | China |
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| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | China |
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| Shanghai Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| Xijing Hospital | Recruiting | Xian | Shanxi | China |
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| West China Hospital | Recruiting | Chengdu | Sichuan | China |
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| Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | China |
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| Sir Run Run Shaw Hospital of Zhejiang | Recruiting | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D001022 | Aortic Valve Insufficiency |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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