aortic stenosis
Conditions
Interventions
Bivalirudin :Bivalirudin as the procedural anticoagulant agent
Heparin :Heparin as the procedural anticoagulant agent
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. More than 18 years old; 2. Diagnosed as symptomatic severe aortic stenosis; 3. The heart team consider the patients not suitable for surgical aortic valve replacement due to high surgical risk; 4. Qualified for transfemoral aortic valve implantation after CT based evaluation of aortic root and peripheral vascular anatomy; 5. Considered at high risk of bleeding by definition; 6. Attend this clinical trial voluntarily and has signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Have contraindication for bivalirudin; 2. Have acute myocardial infarction within 30 days before TAVI; 3. In need of PCI at the time of TAVI; 4. Occured cerebral events or TIA in past 6 months; 5. Receive dialysis or serum creatinine >3mg/dl.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any bleeding events or decrease of Hb > 2.0 g/dl during hospitalization or with 7 days after TAVI;Adverse cardiovascular events within 30 days after TAVI; | — |
Countries
China
Contacts
Public ContactChen Mao
Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China
Outcome results
None listed