Vascular Closure Device in Transcatheter Aortic Valve Replacement

Karolinska University Hospital

Status: Unknown

Conditions: Aortic Valve Stenosis

Treatments: Device: MANTA vascular closure device

Study type: Observational

Funder types: Other

Identifiers

NCT04392492

MANTA TAVI

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

Patients undergoing transfemoral TAVI with MANTA closure

Description:

Patients undergoing transfemoral transcatheter aortic valve replacement with femoral access site closure using the novel plug-based vascular closure device (MANTA, Teleflex/Essential Medical Inc., Malvern, Pennsylvania, USA).

Treatment:

Device: MANTA vascular closure device