To investigate whether the collagen-based MANTA vascular closure device (VCD) is superior to suture-based VCDs in preventing vascular access site complications in patients undergoing transfemoral transcatheter aortic valve replacement.
see summary
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
151
Collagen based vascular closure device
Suture based vascular closure device (ProGlide)
Erasmus University Medical Center Rotterdam
Rotterdam, Netherlands
Composite rate of major- and minor vascular complications according to VARC-2
The primary endpoint will consist of the composite of major- and minor vascular complications according to the Valve Academic Research Consortium (VARC)-2 at 30 days follow-up.
Time frame: Between transcatheter aortic valve implantation and 30 days follow-up
Number of Participants with a Major Vascular Complication according to VARC-2
total number of participants major vascular complications
Time frame: Between transcatheter aortic valve implantation and 30 days follow-up
Number of Participants with a Minor Vascular Complication according to VARC-2
total number of participants minor vascular complications
Time frame: Between transcatheter aortic valve implantation and 30 days follow-up
All-cause death rate
A distinction between cardiac-, non-cardiac vascular and non-cardiovascular death will be made
Time frame: Between transcatheter aortic valve implantation and 30 days follow-up
Number of Participants with a major- or life threatening bleeding according to VARC-2
total number of participants with major/life-threatening bleedings
Time frame: Between transcatheter aortic valve implantation and 30 days follow-up
Need for transfusions for access site related bleeding/complications
Total number of transfusions of RBC because of site-related bleeding
Time frame: Between transcatheter aortic valve implantation and 30 days follow-up
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Number of Participants with vascular closure device failure
Failure of a closure device to achieve haemostasis at the arteriotomy site leading to alternative treatment (other than manual compression or adjunctive endovascular ballooning)
Time frame: Between transcatheter aortic valve implantation and 30 days follow-up
Time to hemostasis
After the use of a vascular closure device the time to hemostasis will be classified as immediate hemostasis, hemostasis after 5 minutes manual compression, hemostasis after 10 minutes manual compression, hemostasis after endovascular ballooning, hemostasis after endovascular intervention or hemostasis after surgical intervention
Time frame: During the TAVI procedure
Total procedure time
The total procedural time in minutes will be compared between the two treatment arms
Time frame: During the TAVI procedure
Number of Participants with a clinically relevant bleeding defined as BARC 2, 3 and 5
Clinically relevant bleeding defined as BARC 2, 3 and 5
Time frame: Between transcatheter aortic valve implantation and 30 days follow-up
Length of hospital stay
The total length of hospital stay in days will be compared between the two treatment arms
Time frame: Up to a maximum of 30 days after the TAVI procedure