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

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Brief Title

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

Official Title

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

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.

Detailed Description

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

Study Type

Interventional

Primary Outcome

Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition

Secondary Outcome

 Rate of access-site or access-related vascular injury

Condition

Aortic Valve Stenosis

Intervention

Manta

Study Arms / Comparison Groups

 Manta
Description:  plug-based vascular closure

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

516

Start Date

June 29, 2020

Completion Date

August 31, 2021

Primary Completion Date

June 28, 2021

Eligibility 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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Mohamed Abdel-Wahab, PD Dr., +49 341 865 1425, [email protected]

Administrative Informations

NCT ID

NCT04459208

Organization ID

HCRI2020-0191

Responsible Party

Sponsor

Study Sponsor

Leipzig Heart Institute GmbH

Study Sponsor

Mohamed Abdel-Wahab, PD Dr., Principal Investigator, Herzzentrum Leipzig GmbH

Verification Date

July 2020