Status:
COMPLETED
Manta™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial
Lead Sponsor:
Erasmus Medical Center
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 tran...
Detailed Description
see summary
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT03811119
Start Date
October 30 2018
End Date
April 30 2020
Last Update
March 29 2021
Active Locations (1)
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1
Erasmus University Medical Center Rotterdam
Rotterdam, Netherlands, 3000 CA