Clinical trial NCT06101888: Safety and Effectiveness of TaurusTrio™ Heart Valve System in Patients With Severe Aortic Regurgitation (AR)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Regurgitation
Lead sponsor: Peijia Medical Technology (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-26
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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;

Primary outcomes:
measure: All-cause mortality at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Improvement in quality of life (QoL) at 12 months over baseline, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).
timeFrame: 12 months
measure: Composite safety endpoint at 30 days
timeFrame: 30 days after procedure
Other outcomes:
measure: Technical Success at exit from OR, hybrid room or cath lab post-index procedure
timeFrame: Immediate after procedure
measure: Device Success at 1-month consisting of
timeFrame: 30 days after procedure
measure: Procedural Success at 1-month consisting of
timeFrame: 30 days after procedure
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
city: Beijing
country: China
facility: Fu Wai Hospital, Beijing, China
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Xiamen
country: China
facility: XiaMen Cardiovascular Hospital XiaMen University
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangdong
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangzhou
city: Haerbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union Hospital, China
state: Hubei
city: Changsha
country: China
facility: Second Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Namchang Umiversity
state: Jiangxi
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
city: Xian
country: China
facility: Xijing Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang
state: Zhejiang
Study officials:
References: