Vascular Closure Device in Transcatheter Aortic Valve Replacement

• Conditions: Aortic Valve Stenosis
• Interventions: Device: MANTA vascular closure device

• Registration Number: NCT04392492
• Lead Sponsor: Karolinska University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-25
• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-18
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-30
• Last Update Posted: 2020-12-02
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing transfemoral TAVI with MANTA closure	MANTA vascular closure device	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).

Primary Outcome Measures

Name	Time	Method
Number of patients with major vascular complications	6 week follow up	Major vascular access site complications according to the VARC-2 definitions

Secondary Outcome Measures

Name	Time	Method
Number of patients with minor vascular complications	6 week follow up	Minor vascular access site complications according to the VARC-2 definitions
Number of patients with vascular closure device failure	6 week follow up	Percutaneous vascular closure device failure according to the VARC-2 definitions
Number of patients with life-threatening, disabling or major bleeding	6 week follow up	Life-threatening, disabling or major bleeding complications according to the BARC definitions

Trial Locations

Locations (1)

Department of Cardiology, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden