Plug-based Percutaneous Vascular Closure Device in Transcatheter Aortic Valve Replacement

Karolinska University Hospital1 site in 1 country1,000 target enrollmentJanuary 25, 2017

ConditionsAortic Valve Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Karolinska University Hospital
Enrollment: 1000
Locations: 1
Primary Endpoint: Number of patients with major vascular complications
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Evaluation of the safety and efficacy of a percutaneous plug-based large-bore vascular closure device for femoral artery closure in an unselected consecutive patient cohort undergoing transcatheter aortic valve implantation in a single-center prospective study.

Registry

clinicaltrials.gov

Start Date

January 25, 2017

End Date

January 31, 2021

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Karolinska University Hospital

Responsible Party

Principal Investigator

Magnus Dalén

Associate professor

Karolinska University Hospital

Eligibility Criteria

Inclusion Criteria

•Patients undergoing transfemoral TAVI at the Karolinska University Hospital

Exclusion Criteria

•Patients undergoing TAVI with access other than transfemoral
•Use of closure device other than MANTA

Outcomes

Primary Outcomes

Number of patients with major vascular complications

Time Frame: 6 week follow up

Major vascular access site complications according to the VARC-2 definitions

Secondary Outcomes

Number of patients with minor vascular complications(6 week follow up)
Number of patients with vascular closure device failure(6 week follow up)
Number of patients with life-threatening, disabling or major bleeding(6 week follow up)