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Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation (CHOICE-CLOSURE)

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ClinicalTrials.gov Identifier: NCT04459208
Recruitment Status : Not yet recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Leipzig Heart Institute GmbH

Brief Summary:
The aim of the study is to evaluate the clinical efficacy of 2 different vascular closure device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI). The study hypothesizes that the choice of one over the other VCD in patients undergoing transfemoral TAVI may demonstrate relevant differences in the rate of peri-procedural complications and effectiveness of vascular closure.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: Manta Device: ProGlide Not Applicable

Detailed Description:
Use of a plug-based VCD in patients undergoing transfemoral TAVI as compared to a suture-based VCD.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 516 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Investigator-initiated, single-center, prospective, open-label randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation
Estimated Study Start Date : June 29, 2020
Estimated Primary Completion Date : June 28, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Manta
plug-based vascular closure
Device: Manta
plug-based vascular closure

Active Comparator: ProGlide
suture-based vascular closure
Device: ProGlide
suture-based vascular closure




Primary Outcome Measures :
  1. Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition [ Time Frame: up to 7 days ]
    Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition


Secondary Outcome Measures :
  1. Rate of access-site or access-related vascular injury [ Time Frame: 30 days ]
    Rate of access-site or access-related vascular injury

  2. Rate of major access-site or access-related vascular injury [ Time Frame: up to 7 days and at 30 days ]
    Rate of major access-site or access-related vascular injury

  3. Rate of minor access site or access-related vascular injury [ Time Frame: up to 7 days and at 30 days ]
    Rate of minor access site or access-related vascular injury

  4. Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria [ Time Frame: up to 7 days and at 30 days) ]
    Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria

  5. all-cause death [ Time Frame: up to 7 days and 30-day ]
    all-cause death

  6. death attributed to access-site or access-related complications [ Time Frame: up to 7 days and 30-day ]
    death attributed to access-site or access-related complications

  7. Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site [ Time Frame: up to 7 days ]
    Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other

  8. access-site or access-related disabling/life- threatening bleeding according to BARC [ Time Frame: up to 7 days and 30-day ]
    access-site or access-related disabling/life- threatening bleeding according to BARC

  9. access-site or access-related major bleeding according to BARC [ Time Frame: up to 7 days and 30-day ]
    access-site or access-related major bleeding according to BARC

  10. access-site or access-related minor bleeding according to BARC [ Time Frame: up to 7 days and 30-day ]
    access-site or access-related minor bleeding according to BARC

  11. Need for blood transfusion for access-site or access-related bleeding or vascular complications [ Time Frame: up to 7 days ]
    Need for blood transfusion for access-site or access-related bleeding or vascular complications

  12. Total number of blood transfusions because of access-site or access-related bleeding [ Time Frame: up to 7 days ]
    Total number of blood transfusions because of access-site or access-related bleeding

  13. Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis [ Time Frame: 24 hours ]
    Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis

  14. Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment [ Time Frame: 24 hours ]
    Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment

  15. Length of postprocedural hospital stay [ Time Frame: up to 7 days ]
    Length of postprocedural hospital stay

  16. Time to hemostasis, defined as the time from VCD application to complete hemostasis [ Time Frame: 24 hours ]
    Time to hemostasis, defined as the time from VCD application to complete hemostasis

  17. Need and number of additional unplanned VCDs [ Time Frame: 24 hours ]
    Need and number of additional unplanned VCDs

  18. Percent diameter stenosis of vascular access vessel on post-procedural angiography [ Time Frame: 24 hours ]
    Percent diameter stenosis of vascular access vessel on post-procedural angiography



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:

  1. Patients with an indication for transfemoral TAVI as judged by the local heart team.
  2. Transfemoral access route and a commercially-available transcatheter aortic valve is selected by the local heart team.
  3. The patient is willing to provide written informed consent and comply with protocol- specified follow-up evaluations.

Exclusion Criteria:

  1. Vascular access site anatomy not suitable for percutaneous vascular closure.
  2. Vascular access site complications prior to the TAVI procedure.
  3. Known allergy or hypersensitivity to any VCD component.
  4. Unstable active bleeding/ bleeding diathesis or significant unmanageable anemia.
  5. Absence of computed tomographic data of the access site before the procedure.
  6. Systemic infection or a local infection at or near the access site.
  7. Life expectancy of less than 6 months due to non-cardiac conditions.
  8. Patient cannot adhere to or complete the investigational protocol for any reason.
  9. Pregnant or nursing subjects.
  10. Participation in any other interventional trial.

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): NCT04459208


Contacts
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Contact: Mohamed Abdel-Wahab, PD Dr. +49 341 865 1425 mohamed.abdel-wahab@medizin.uni-leipzig.de

Sponsors and Collaborators
Leipzig Heart Institute GmbH
Investigators
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Principal Investigator: Mohamed Abdel-Wahab, PD Dr. Herzzentrum Leipzig GmbH
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Responsible Party: Leipzig Heart Institute GmbH
ClinicalTrials.gov Identifier: NCT04459208    
Other Study ID Numbers: HCRI2020-0191
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leipzig Heart Institute GmbH:
Vascular access site closure
Transcatheter aortic valve implantation
Vascular closure device
Vascular access-site injury
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction