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.
ID
Source
Brief title
Condition
- Cardiac valve disorders
- Vascular injuries
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The composite of major vascular complications, and minor vascular complications
according to VARC 2 at 30 days.
Secondary outcome
- The individual components of the primary endpoint at 30 days and 1 year:
major- and minor vascular complications defined bij VARC 2.
- All-cause death including cardiac death, non-cardiac vascular death,
non-cardiovascular death.
- Major or life threatening bleedings according to VARC 2
- Need for transfusions for access site related bleeding/complications
- Vascular closure device failure, defined as: placement of VCD not possible or
failure of a closure device to achieve haemostasis at the arteriotomy site
leading to alternative treatment (other than manual compression or adjunctive
endovascular ballooning)
- Intra-procedural complications at the femoral access site pre-sheath removal
including bleeding or swelling around the large bore sheath that may indicate
hematoma formation or pseudoaneurysm formation; or peri-procedural angiographic
evidence of thrombus formation or significant injury in the aorta or iliac
vessels associated with procedural large bore sheath placement and/or
sub-optimal anticoagulation.
- Time to haemostasis: elapsed time (minutes) between sheath removal and
observed haemostasis
- Procedure time
- Time to ambulation (TTA)
- Ambulation success
- Technical success
- Treatment success
- Clinically relevant bleeding defined as BARC 2, 3 and 5
- Length of hospital stay
- Pain and discomfort score
Background summary
The majority of Transcatheter Aortic Valve Implantation (TAVI) procedures is
performed through a transfemoral approach. To reach haemostasis several
vascular closure devices (VCD) are currently available. Vascular complications
are relatively frequent and are often associated with closure device failure.
Study objective
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.
Study design
A single-center, investigator-driven, randomized, adaptive open label study
Intervention
One group will undergo arteriotomy closure with the suture-based vascular
closure device, the other group will undergo arteriotomy closure with a
collagen-based MANTA device
Study burden and risks
There is no extra burden or risk associated with participation as all
techniques and inquiries are standard care for our TAVI-patients.
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
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 such as a 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66778.078.18 |