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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Aortic Regurgitation
• Intervention / Treatment: Device: TaurusTrio™ Heart Valve System

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: jing ren; Phone Number: 18550112597; Email: renjing@peijiamedical.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 215025
      • Recruiting
      • Beijing Anzhen Hospital
      • Contact: guangyuan Song
    • Beijing, Beijing, China
      • Recruiting
      • Fu Wai Hospital, Beijing, China
      • Contact: Yongjian Wu
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Fujian Medical University Union Hospital
      • Contact: lianglong chen
      • Contact: liangwan chen
    • Xiamen, Fujian, China
      • Recruiting
      • Xiamen Cardiovascular Hospital Xiamen University
      • Contact: Yan Wang
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangdong Provincial People's Hospital
      • Contact: jianfang Luo
  • Guangzhou
    • Guangdong, Guangzhou, China
      • Recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: Jiancheng Xiu
  • Heilongjiang
    • Haerbin, Heilongjiang, China
      • Recruiting
      • The Second Affiliated Hospital of Harbin Medical University
      • Contact: bo Yu
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Renmin Hospital of Wuhan University
      • Contact: Hong Jiang
    • Wuhan, Hubei, China
      • Recruiting
      • Wuhan Union Hospital, China
      • Contact: Xiang Cheng
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Second Xiangya Hospital of Central South University
      • Contact: Shenghua Zhou
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Nanjing First Hospital
      • Contact: shaoliang Chen
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Recruiting
      • The First Affiliated Hospital of Namchang Umiversity
      • Contact: Xiaoping Peng
  • Liaoning
    • Shenyang, Liaoning, China
      • Recruiting
      • General Hospital of Northern Theater Command
      • Contact: Yaling Han
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: guipeng An
      • Contact: xinghua Gu
      • Principal Investigator: chuanbao Li
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Zhongshan Hospital
      • Contact: Junbo Ge
  • Shanxi
    • Xian, Shanxi, China
      • Recruiting
      • Xijing Hospital
      • Contact: Jian Yang
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital
      • Contact: Mao Chen
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: jianan Wang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Sir Run Run Shaw Hospital of Zhejiang
      • Contact: guosheng Fu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A single set of test; The experimental apparatus consisted of TaurusTrio™ Heart Valve (THV), Delivery Catheter & Introducer Sheath ,Loading Tools	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality at 12 months	All-cause mortality	12 months

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2029

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Valve Insufficiency
• Other Study ID Numbers: 15CSP001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No