Manta™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial

MANTA™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial

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

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