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Tests treatment safety and results for Aortic Regurgitation
Official title Safety and Effectiveness of TaurusTrio™ Heart Valve System in Patients With Severe Aortic Regurgitation (AR)
ClinicalTrials.gov ID: NCT06101888
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients who voluntarily participate and sign the informed consent and are able to comply with the entire trial process;
- Age ≥ 18 years;
- Adult people with severe AR (Grade ≥ 3) as assessed by echocardiography based on ASE (American Society of Echocardiography) using multiparametric...
- Jet width ≥ 65% of LVOT
- Vena contracta width of \> 6 mm
You likely can't join 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...
- Echocardiographic evidence of left ventricular thrombus；
- Endocarditis within 180 days prior to index procedure；
See the full eligibility criteria
Who can join
- Patients who voluntarily participate and sign the informed consent and are able to comply with the entire trial process;
- Age ≥ 18 years;
- Adult people 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...
- 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...
- Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy™ Heart Valve System，evaluated by core laboratory;
What rules you out
- 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 \ 28.6 mm or perimeter \ 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...
- 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...
- Unable to comply with follow-up requirements;
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Xiamen, Fujian, China
- Guangzhou, Guangdong, China
- Guangdong, Guangzhou, China
- Haerbin, Heilongjiang, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Nanchang, Jiangxi, China
- Shenyang, Liaoning, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Xian, Shanxi, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Xiamen, Fujian, China; Guangzhou, Guangdong, China; Guangdong, Guangzhou, China; Haerbin, Heilongjiang, China and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.