Brief Title
Manta™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial
Official Title
MANTA™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial
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.
Study Type
Interventional
Primary Outcome
Composite rate of major- and minor vascular complications according to VARC-2
Secondary Outcome
Number of Participants with a Major Vascular Complication according to VARC-2
Condition
Aortic Valve Stenosis
Intervention
MANTA vascular closure device
Study Arms / Comparison Groups
MANTA vascular closure device
Description: Arteriotomy closure with a collagen-based vascular closure device (MANTA™)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
210
Start Date
October 30, 2018
Completion Date
March 2020
Primary Completion Date
January 2020
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Nicolas M Van Mieghem, MD, PhD, +31107035260, [email protected]
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT03811119
Organization ID
MASH TAVI 06-09-2018
Responsible Party
Principal Investigator
Study Sponsor
Erasmus Medical Center
Study Sponsor
Nicolas M Van Mieghem, MD, PhD, Principal Investigator, Erasmus University Medical Center Rotterdam
Verification Date
January 2019