Aortic Valve Stenosis
Conditions
Keywords
Vascular Closure Devices, Transcatheter Aortic Valve Implantation
Brief summary
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.
Detailed description
see summary
Interventions
Collagen based vascular closure device
DEVICESuture based vascular closure device
Suture based vascular closure device (ProGlide)
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing elective transfemoral TAVI for severe aortic valve stenosis with any commercially-available transcatheter heart valve (THV) * Common femoral artery diameter \> 5.0mm (14 - 22F compatible)
Exclusion criteria
* Symptomatic leg ischaemia * Previous thromboendarterectomy or plastic patch of the common femoral artery * Previous implantation of a suture-based VCD less than 30 days before, or a plug-based VCD within 6 months * Unilateral or bilateral lower extremity amputation * Systemic infection or a local infection at or near the access site * Allergy to the components any of both devices (i.e. bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel) * Active bleeding or bleeding diathesis including thrombocytopenia (platelet count \<50,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease * Patients in whom continuous oral anticoagulation therapy cannot be stopped for the peri-procedural period or patients with INR \>1.8 at the time of the procedure * Patient unable to be adequately anti-coagulated for the procedure * Morbidly obese or cachectic (BMI \>40 kg/m2 or \<20 kg/m2) * Anatomical and procedural contraindication for suture-based or Manta closure (lack of proper puncture site in the common femoral artery in terms of calcification, size, and atherosclerotic disease) * Absence of computed tomographic data of the access site before the procedure * Patient cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life threatening disease * Known pregnancy at time of randomization (in women of childbearing potential a negative pregnancy test is mandatory) * Participating in trials in which the primary endpoint includes bleeding or vascular complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite rate of major- and minor vascular complications according to VARC-2 | Between transcatheter aortic valve implantation and 30 days follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with a Minor Vascular Complication according to VARC-2 | Between transcatheter aortic valve implantation and 30 days follow-up | total number of participants minor vascular complications |
| All-cause death rate | Between transcatheter aortic valve implantation and 30 days follow-up | A distinction between cardiac-, non-cardiac vascular and non-cardiovascular death will be made |
| Number of Participants with a major- or life threatening bleeding according to VARC-2 | Between transcatheter aortic valve implantation and 30 days follow-up | total number of participants with major/life-threatening bleedings |
| Need for transfusions for access site related bleeding/complications | Between transcatheter aortic valve implantation and 30 days follow-up | Total number of transfusions of RBC because of site-related bleeding |
| Number of Participants with a Major Vascular Complication according to VARC-2 | Between transcatheter aortic valve implantation and 30 days follow-up | total number of participants major vascular complications |
| Time to hemostasis | During the TAVI procedure | 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 |
| Total procedure time | During the TAVI procedure | The total procedural time in minutes will be compared between the two treatment arms |
| Number of Participants with a clinically relevant bleeding defined as BARC 2, 3 and 5 | Between transcatheter aortic valve implantation and 30 days follow-up | Clinically relevant bleeding defined as BARC 2, 3 and 5 |
| Length of hospital stay | Up to a maximum of 30 days after the TAVI procedure | The total length of hospital stay in days will be compared between the two treatment arms |
| Number of Participants with vascular closure device failure | Between transcatheter aortic valve implantation and 30 days follow-up | Failure of a closure device to achieve haemostasis at the arteriotomy site leading to alternative treatment (other than manual compression or adjunctive endovascular ballooning) |
Countries
Netherlands
Outcome results
None listed