Aortic Valve Stenosis Clinical Trial
Official title:
Efficacy Comparison of Different Femoral Vascular Closure Method Following Percutaneous Transcatheter Aortic Valve Implantation
Femoral artery approach for transcatheter aortic valve implantation (TAVI) is an ideal approach site. However the closure for femoral artery after transfemoral TAVI is challenging. We aimed to compared the efficacy and safety of Angio-Seal + Proglide vs. Dual Proglide for femoral arteriotomy closure following TAVI
Status | Recruiting |
Enrollment | 200 |
Est. completion date | June 30, 2023 |
Est. primary completion date | October 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - Age >= 20 years old - Severe aortic stenosis and suitable candidate for transfemoral transcatheter aortic valve implantation Exclusion Criteria: - Age < 20 years old - Severe aortic stenosis not suitable for transfemoral transcatheter aortic valve implantation |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vascular complication | TAVI related major or minor vascular complication according to valve academic research consortium 3 criteria | during hospitalization for index procedure | |
Primary | Life threatening bleeding complication | TAVI related life threatening bleeding according valve academic research consortium 3 criteria | within 24hrs after the index procedure | |
Primary | Major or minor bleeding complication without life threatening condition | TAVI related major or minor bleeding according valve academic research consortium 3 without life threatening condition | within 24hrs after the index procedure | |
Secondary | Bail-out closure device use | additional closure device deployment for femoral access site to achieve hemostasis | within 24hrs after the index procedure | |
Secondary | Limb ischemia related to TAVI | Significant peripheral ischemia related to arteriotomy closure within one year of follow-up | within 24hrs after the index procedure |
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