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

NCT06101888 | Recruiting

• 1 other identifier: 15CSP001
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 19

Brief 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).

Conditions

Aortic Regurgitation

Outcome Measures

Primary Outcomes (1)

• All-cause mortality at 12 months

  All-cause mortality

  12 months

Secondary Outcomes (2)

• Improvement in quality of life (QoL) at 12 months over baseline, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).

  12 months

• Composite safety endpoint at 30 days

  30 days after procedure

Other Outcomes (3)

• Technical Success at exit from OR, hybrid room or cath lab post-index procedure

  Immediate after procedure

• Device Success at 1-month consisting of

  30 days after procedure

• Procedural Success at 1-month consisting of

  30 days after procedure

Study Arms (1)

A single set of test

EXPERIMENTAL

The experimental apparatus consisted of TaurusTrio™ Heart Valve (THV), Delivery Catheter \& Introducer Sheath ,Loading Tools

Device: TaurusTrio™ Heart Valve System

Interventions

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.

A single set of test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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；

Sponsors & Collaborators

• Peijia Medical Technology (Suzhou) Co., Ltd.: lead

Study Sites (19)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 215025, China

RECRUITING

Fu Wai Hospital, Beijing, China

Beijing, Beijing Municipality, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

RECRUITING

XiaMen Cardiovascular Hospital XiaMen University

Xiamen, Fujian, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Nanfang Hospital, Southern Medical University

Guangdong, Guangzhou, China

RECRUITING

The Second Affiliated Hospital of Harbin Medical University

Haerbin, Heilongjiang, China

RECRUITING

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

RECRUITING

Wuhan Union Hospital, China

Wuhan, Hubei, China

RECRUITING

Second Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Nanjing First Hospital

Nanjing, Jiangsu, China

RECRUITING

The First Affiliated Hospital of Namchang Umiversity

Nanchang, Jiangxi, China

RECRUITING

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Xijing Hospital

Xian, Shanxi, China

RECRUITING

West China Hospital

Chengdu, Sichuan, China

RECRUITING

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Sir Run Run Shaw Hospital of Zhejiang

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

jing ren

CONTACT

18550112597; renjing@peijiamedical.com

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 20, 2023
• First Posted: October 26, 2023
• Study Start: August 1, 2023
• Primary Completion: July 31, 2024
• Study Completion (Estimated): July 31, 2029
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

CN (19)