Manta™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial (MASH-TAVI)

Erasmus University

Status

Completed

Conditions

Aortic Valve Stenosis

Treatments

Device: MANTA vascular closure device

Device: Suture based vascular closure device

Study type

Interventional

Funder types

Other

Identifiers

NCT03811119

MASH TAVI 06-09-2018

Details and patient eligibility

About

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.

Full description

see summary

Enrollment

151 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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