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

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ClinicalTrials.gov Identifier: NCT03811119
Recruitment Status : Recruiting
First Posted : January 21, 2019
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
Nicolas van Mieghem, Erasmus Medical Center

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: MANTA vascular closure device Device: Suture based vascular closure device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open label randomized trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MANTA™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial
Actual Study Start Date : October 30, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: MANTA vascular closure device
Arteriotomy closure with a collagen-based vascular closure device (MANTA™)
Device: MANTA vascular closure device
Collagen based vascular closure device

Active Comparator: Suture based vascular closure device
Arteriotomy closure with 2 or more suture-based vascular closure devices (ProGlide)
Device: Suture based vascular closure device
Suture based vascular closure device (ProGlide)




Primary Outcome Measures :
  1. Composite rate of major- and minor vascular complications according to VARC-2 [ Time Frame: Between transcatheter aortic valve implantation and 30 days follow-up ]
    The primary endpoint will consist of the composite of major- and minor vascular complications according to the Valve Academic Research Consortium (VARC)-2 at 30 days follow-up.


Secondary Outcome Measures :
  1. Number of Participants with a Major Vascular Complication according to VARC-2 [ Time Frame: Between transcatheter aortic valve implantation and 30 days follow-up ]
  2. Number of Participants with a Minor Vascular Complication according to VARC-2 [ Time Frame: Between transcatheter aortic valve implantation and 30 days follow-up ]
  3. All-cause death rate [ Time Frame: Between transcatheter aortic valve implantation and 30 days follow-up ]
    A distinction between cardiac-, non-cardiac vascular and non-cardiovascular death will be made

  4. Number of Participants with a major- or life threatening bleeding according to VARC-2 [ Time Frame: Between transcatheter aortic valve implantation and 30 days follow-up ]
  5. Need for transfusions for access site related bleeding/complications [ Time Frame: Between transcatheter aortic valve implantation and 30 days follow-up ]
    Total number of transfusions of RBC because of site-related bleeding

  6. Number of Participants with vascular closure device failure [ Time Frame: Between transcatheter aortic valve implantation and 30 days follow-up ]
    Failure of a closure device to achieve haemostasis at the arteriotomy site leading to alternative treatment (other than manual compression or adjunctive endovascular ballooning)

  7. Time to hemostasis [ Time Frame: During the TAVI procedure ]
    After the use of a vascular closure device the time to hemostasis will be classified as immediate hemostasis, hemostasis after 5 minutes manual compression, hemostasis after 10 minutes manual compression, hemostasis after endovascular ballooning, hemostasis after endovascular intervention or hemostasis after surgical intervention

  8. Total procedure time [ Time Frame: During the TAVI procedure ]
    The total procedural time in minutes will be compared between the two treatment arms

  9. Number of Participants with a clinically relevant bleeding defined as BARC 2, 3 and 5 [ Time Frame: Between transcatheter aortic valve implantation and 30 days follow-up ]
    Clinically relevant bleeding defined as BARC 2, 3 and 5

  10. Length of hospital stay [ Time Frame: Up to a maximum of 30 days after the TAVI procedure ]
    The total length of hospital stay in days will be compared between the two treatment arms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811119


Contacts
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Contact: Nicolas M Van Mieghem, MD, PhD +31107035260 n.vanmieghem@erasmusmc.nl
Contact: Maarten P van Wiechen, MD +31107038896 m.vanwiechen@erasmusmc.nl

Locations
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Netherlands
Erasmus University Medical Center Rotterdam Recruiting
Rotterdam, Netherlands, 3000 CA
Contact: Nicolas M Van Mieghem, MD,PhD         
Sponsors and Collaborators
Erasmus Medical Center
Investigators
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Principal Investigator: Nicolas M Van Mieghem, MD, PhD Erasmus University Medical Center Rotterdam

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Responsible Party: Nicolas van Mieghem, Principal Investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT03811119     History of Changes
Other Study ID Numbers: MASH TAVI 06-09-2018
First Posted: January 21, 2019    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Nicolas van Mieghem, Erasmus Medical Center:
Vascular Closure Devices
Transcatheter Aortic Valve Implantation

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction