Aortic valve regurgitation
Conditions
Interventions
Experimental group:Implantation of artificial aortic valve using Taurus TrioTM heart valve system
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who voluntarily participated and signed the informed consent form and could cooperate to complete the whole study process; 2. Age >= 60 years old; 3.For study participants with severe aortic regurgitation (>= grade 3 AR) confirmed by echocardiography, it is recommended to refer to the 2017 ASE/SCMR recommendation : multi-parameter assessment of AR severity in the Noninvasive Evaluation of Native Valve Regurgitation; 4. Study participants had AR related symptoms and New York Heart Association (NYHA) functional class II or above; 5.Participants were assessed by the heart team as being in need of aortic valve replacement but not suitable for conventional surgical treatment and anatomically suitable for the TaurusTrioTM valve system.
Exclusion criteria
Exclusion criteria: 1.Congenital aortic valve malformation (unicuspid, bicuspid, etc.); 2. Prior aortic prosthesis (bioprosthetic or mechanical) implantation; 3.Severe mitral or tricuspid valve disease requiring concomitant therapy; 4.Left heart system thrombosis, intracardiac mass or vegetation on echocardiography; 5.History of endocarditis or other active infection within 180 days before surgery (if not completely cured); 6.Hypertrophic cardiomyopathy with or without obstruction; 7.Severe pulmonary hypertension; 8.Severe right ventricular dysfunction by comprehensive clinical and echocardiographic evaluation; 9.Severely reduced left ventricular ejection fraction (LVEF 28.6mm or circumferential diameter 90mm, as measured by MDCT; 11.Aortic annular horizontal Angle > 80° measured by MDCT; 12. Ascending aorta straight length = 55mm), aortic dissection, etc. 14.Requiring emergency TAVR for any reason; 15.Present with cardiogenic shock or hemodynamic instability requiring positive inotropic support or ventricular assist device within 30 days before surgery; 16.Acute myocardial infarction within 30 days before surgery; 17.Occurrence of cerebrovascular events (including TIA and stroke) within 180 days before surgery; 18.Patients with common carotid or internal carotid or vertebral artery stenosis (>70%) that requires treatment as recommended by relevant discipline consultation; 19.Severe coagulopathy; 20.Had severe renal insufficiency (GFR < 30 mL/ minute) at screening or renal disease requiring renal-replacement therapy within 180 days before the index TAVR procedure; 21. Severe hematological abnormalities; 22.Patients with active peptic ulcer or upper gastrointestinal bleeding within 90 days before surgery; 23. Known to be allergic to heparin, aspirin, ticlopidine, clopidogrel, nitroglycerin and other drugs, and allergic to contrast media, Nitinol alloy, tantalum, pig products; 24. Had contraindications to MDCT scanning; 25. Estimated life expectancy <12 months; 26.Study participants were enrolled in another unfinished clinical study of a medical device or drug that was followed for the primary end point (Note: Study participants who participated in the long-term monitoring phase of the other study were eligible for this study); 27.The investigator considered that the study participant had other medical, social, or psychological conditions that prevented them from providing appropriate informed consent; 28.Severe dementia (resulting in an inability to provide informed consent for clinical research/surgery, or to live independently outside a chronic illness care facility, or to fundamentally make it difficult for study participants to receive rehabilitation or follow-up assessments after surgery); 29.Study participants were unable to comply with the study follow-up requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative 30 day all-cause mortality;Death from any cause;All strokes;Life-threatening bleeding or major bleeding;Acute kidney injury (AKI) stage 2 and 3 (including renal replacement therapy);Major Vascular complications;Valve-related reoperations/interventions (including coronary interventions);A new permanent pacemaker was implanted;Moderate or severe prosthetic aortic regurgitation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success;Device success;The operation was successful;The intraoperative time was recorded;Echocardiographic indicators;Cardiac function assessment; | — |
Countries
China
Contacts
Public ContactMao Chen
West China Hospital, Sichuan University
Outcome results
None listed