Severe aortic regurgitation
Conditions
Interventions
Test Group:TAVI treatment
Sponsors
Zhongshan Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) One of the following conditions is met: a) Age=70 years,STS score=4%; b) Age<70 years and Age=60years,Unassessed by the cardiac team for surgery (e. g. organ failure without severe weakness, surgery-related obstacles, such as severe thoracic deformity of pericardial adhesion after a history of chest radiotherapy, thoracotomy); 2) A diagnosis of severe aortic valve regurgitation (AR) and symptoms caused by AR; 3) NYHA Functional Class =II; 4) Expected survival time after corrective treatment of AR is more than 1 years; 5) Subjects or their agents voluntarily attended and signed the informed consent form,and are willing to accept relevant examinations and clinical follow-up.
Exclusion criteria
Exclusion criteria: 1)intra-cardiac thrombus or vegetation etc; 2)left ventricular outflow tract obstruction; 3)Untreated severe coronary artery stenosis; 4)left ventricular ejection fraction (LVEF) =30%; 5)TSevere pulmonary hypertension or right ventricular dysfunction;.. 6)The vascular approach or aortic root anatomy were not suitable for TAVI; 7)Combined severe mitral regurgitation or mitral stenosis; 8)Allergic to nickel-titanium alloys, cobalt-chromium alloy , contrast agents and related ingredients. 9)cannot receive anticoagulation or antiplatelet therapy; 10)Active endocarditis or other active infections; 11)hepatic failure; 12)Renal dysfunction decompensation (Creatinine > 3.0 mg/dl),and/or end-stage renal disease requires long-term dialysis; 13)Aortic annulus diameter 28mm; 14)Participated in other clinical trials 1 month before the screening; 15)Other circumstances that the researcher deems inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accumulated all-cause mortality at 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate instrument success rate after surgery;Immediate postoperative surgery success rate;Valve function;quality of life;NYHA function;Performance evaluation of supporting equipment;Performance evaluation of recycling system; | — |
Countries
China
Contacts
Public ContactZhou Daxin
Zhongshan Hospital of Fudan University
Outcome results
None listed