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

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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