Vascular Closure Device in Transcatheter Aortic Valve Replacement

Karolinska University Hospital1,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Aortic Valve Stenosis

Interventions

MANTA vascular closure deviceDEVICE

Femoral access site closure using the MANTA closure device

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Department of Cardiology, Karolinska University Hospital

Stockholm, Sweden

Outcomes

Primary Outcomes

Number of patients with major vascular complications

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

Time frame: 6 week follow up

Secondary Outcomes

Number of patients with minor vascular complications

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

Time frame: 6 week follow up

Number of patients with vascular closure device failure

Percutaneous vascular closure device failure according to the VARC-2 definitions

Time frame: 6 week follow up

Number of patients with life-threatening, disabling or major bleeding

Life-threatening, disabling or major bleeding complications according to the BARC definitions

Time frame: 6 week follow up

Data from ClinicalTrials.gov

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