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Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation

NCT05503199 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2024-04-23

No results posted yet for this study

Summary

The ACCESS-TAVI trial is an investigator-initiated, prospective, randomized, multicenter, open-label clinical trial. The objective of the trial is to compare two different vascular closure device strategies for large bore vascular access following transfemoral transcatheter aortic valve implantation with regard to safety and efficacy.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo).

Combined suture- and plug-based VCD strategy after TF-TAVI.

DEVICE

Combination of two ProGlides or ProStyles (Abbott Vascular).

Pure suture-based VCD strategy after TF-TAVI.

Sponsors & Collaborators

  • Deutsches Herzzentrum Muenchen

    lead OTHER

Principal Investigators

  • Michael Joner, MD · Deutsches Herzzentrum München

  • Tobias Rheude, MD · Deutsches Herzzentrum München

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2024-04-18
Completion
2024-04-18

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05503199 on ClinicalTrials.gov