The aim of the study is to evaluate the clinical efficacy of 2 different vascular closure device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI). The study hypothesizes that the choice of one over the other VCD in patients undergoing transfemoral TAVI may demonstrate relevant differences in the rate of peri-procedural complications and effectiveness of vascular closure.
Use of a plug-based VCD in patients undergoing transfemoral TAVI as compared to a suture-based VCD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
516
Herzzentrum Leipzig
Leipzig, Germany
Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition
Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition
Time frame: up to 7 days
Rate of access-site or access-related vascular injury
Rate of access-site or access-related vascular injury
Time frame: 30 days
Rate of major access-site or access-related vascular injury
Rate of major access-site or access-related vascular injury
Time frame: up to 7 days and at 30 days
Rate of minor access site or access-related vascular injury
Rate of minor access site or access-related vascular injury
Time frame: up to 7 days and at 30 days
Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria
Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria
Time frame: up to 7 days and at 30 days)
all-cause death
all-cause death
Time frame: up to 7 days and 30-day
death attributed to access-site or access-related complications
death attributed to access-site or access-related complications
Time frame: up to 7 days and 30-day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site
Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other
Time frame: up to 7 days
access-site or access-related disabling/life- threatening bleeding according to BARC
access-site or access-related disabling/life- threatening bleeding according to BARC
Time frame: up to 7 days and 30-day
access-site or access-related major bleeding according to BARC
access-site or access-related major bleeding according to BARC
Time frame: up to 7 days and 30-day
access-site or access-related minor bleeding according to BARC
access-site or access-related minor bleeding according to BARC
Time frame: up to 7 days and 30-day
Need for blood transfusion for access-site or access-related bleeding or vascular complications
Need for blood transfusion for access-site or access-related bleeding or vascular complications
Time frame: up to 7 days
Total number of blood transfusions because of access-site or access-related bleeding
Total number of blood transfusions because of access-site or access-related bleeding
Time frame: up to 7 days
Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis
Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis
Time frame: 24 hours
Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment
Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment
Time frame: 24 hours
Length of postprocedural hospital stay
Length of postprocedural hospital stay
Time frame: up to 7 days
Time to hemostasis, defined as the time from VCD application to complete hemostasis
Time to hemostasis, defined as the time from VCD application to complete hemostasis
Time frame: 24 hours
Need and number of additional unplanned VCDs
Need and number of additional unplanned VCDs
Time frame: 24 hours
Percent diameter stenosis of vascular access vessel on post-procedural angiography
Percent diameter stenosis of vascular access vessel on post-procedural angiography
Time frame: 24 hours