Safety and Effectiveness of TaurusTrio™ Heart Valve System in Patients With Severe Aortic Regurgitation (AR)

Aortic Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06101888
• Other study ID #: 15CSP001
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: July 31, 2029

Study information

• Verified date: March 2024
• Source: Peijia Medical Technology (Suzhou) Co., Ltd.
• Contact: jing ren
• Phone: 18550112597
• Email: renjing[@]peijiamedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: July 31, 2029
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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:

• Congenital uni- or bicuspid aortic valve morphology;

• 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;

Related Conditions & MeSH terms

• Aortic Regurgitation
• Aortic Valve Insufficiency

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing
China	Fu Wai Hospital, Beijing, China	Beijing	Beijing
China	Second Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital	Chengdu	Sichuan
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Nanfang Hospital, Southern Medical University	Guangdong	Guangzhou
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Harbin Medical University	Haerbin	Heilongjiang
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Sir Run Run Shaw Hospital of Zhejiang	Hangzhou	Zhejiang
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	The First Affiliated Hospital of Namchang Umiversity	Nanchang	Jiangxi
China	Nanjing First Hospital	Nanjing	Jiangsu
China	Shanghai Zhongshan Hospital	Shanghai	Shanghai
China	General Hospital of Northern Theater Command	Shenyang	Liaoning
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Wuhan Union Hospital, China	Wuhan	Hubei
China	XiaMen Cardiovascular Hospital XiaMen University	Xiamen	Fujian
China	Xijing Hospital	Xian	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Peijia Medical Technology (Suzhou) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	All-cause mortality at 12 months	All-cause mortality	12 months
Secondary	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
Secondary	Composite safety endpoint at 30 days	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