Autologous aortic valve regurgitation with a severity of =3Patients with autologous aortic valve regurgitation of grade >= 3
Conditions
Interventions
Experimental group(TAVR group):Transcatheter Aortic Valve Replacement
Control group(SVAR):Surgical Aortic Valve Replacement
Sponsors
The second affiliated hospital of Zhejiang University school of medicine
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=65 years; 2. a. Symptomatic patients with severe AR; 1.b. Asymptomatic patients with severe AR and evidence of LV function impairment (per current ESC / ACC guidelines) Any of the following perimeters; 1) LVEF 50 mm; 3) LVESDi >22 mm/m^2; 4) LVESVi >45 mL/m^2; 5) normal LV systolic function at rest (LVEF >55%), and a progressive decline in LVEF on at least 3 serial studies to the low-normal range (LVEF 55% to 60%) or a progressive increase in LV dilation into the severe range (LV end-diastolic dimension [LVEDD] >65 mm); 3. Evaluated by a multi-disciplinary heart team to be suitable for both surgery and transcatheter valve replacement; 4. Informed of the nature of the study, agrees to its provisions, has provided written informed consent, and agrees to comply with all required post-procedure follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Confirmed moderate or less AR severity (Grade94 mm measured by CT; 2) Maximal ascending aortic diameter >=50mm; 3) Congenital aortic valve disease including unicuspid, bicuspid, or quadricuspid aortic valve anatomy; 4) Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (e.g., calcification, tortuosity). 5) Significant abdominal or thoracic aortic disease (such as porcelain aorta, severe calcification, aortic coarctation, etc.) that preclude safe passage of the delivery system or cannulation and aortotomy for surgical AVR. 10. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit; 11. Cardiac resynchronization therapy (CRT) device implantation within 30 days of the screening visit; 12. Any condition considered a contraindication to mechanical circulatory support; 13. Hostile chest or conditions or complications from prior surgery that preclude safe reoperation (e.g., mediastinitis, radiation damage, abnormal chest wall, adhesion of aorta or IMA to sternum, etc.); 14. Subject refuses blood transfusion; 15. Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention; 16. Evidence of acute myocardial infarction within 30 days of the screening visit; 17. Any percutaneous coronary or peripheral interventional procedure performed within 30 days of the screening visit (Subjects with placement of coronary or peripheral stent(s) should be assessed for the ability to safely proceed with SAVR within the protocol timeframe); 18. Complex coronary artery disease (one of the following):; 1) Unprotected left main coronary artery disease >=50%; 2) True bifurcation lesion (Medina: 1.1.1) and the diameter of the branch vessels is >2.5 mm; 3) Chronic total occlusion (CTO); 4) Long lesion, expected stent length >38 mm; 5) Multivessel lesion (at least 2 coronary arteries require interventional treatment); 6) Need to use multiple stents (planned > 3 stents); 7) Lesion with in-stent restenosis; 8) Severe calcification lesion; 9) Coronary ostial lesion; 10) Heart Team assessment that optimal revascularization cannot be performed with either CABG at the time of SAVR or PCI at the time of TAVR. 19. Symptomatic carotid or vertebral artery disease or carotid intervention within 30 days of the screening visit; 20. Stroke or transient ischemic attack (TIA) within 90 days of the screening visit; 21. Severe left ventricular dysfunction, defined as a resting left ventricular ejection fraction 70mm; or the presence of an artificial heart or left ventricular assist device; or being listed for heart transplantation or status post heart transplantation; 22. Mo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All strokes occurring one year after surgery;All-cause mortality 1 year after surgery;Unplanned cardiovascular readmission one year after surgery; | — |
Countries
China
Contacts
Public ContactYuchao Guo; Jian'an Wang
The second affiliated hospital of Zhejiang University school of medicine
Outcome results
None listed