Vascular Closure Device in Transcatheter Aortic Valve Replacement

Aortic Valve Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04392492
• Other study ID #: MANTA TAVI
• Status: Active, not recruiting
• Start date: January 25, 2017
• Est. completion date: January 31, 2021

Study information

• Verified date: November 2020
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: January 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• MANTA vascular closure device
Femoral access site closure using the MANTA closure device

Locations

Country	Name	City	State
Sweden	Department of Cardiology, Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with major vascular complications	Major vascular access site complications according to the VARC-2 definitions	6 week follow up
Secondary	Number of patients with minor vascular complications	Minor vascular access site complications according to the VARC-2 definitions	6 week follow up
Secondary	Number of patients with vascular closure device failure	Percutaneous vascular closure device failure according to the VARC-2 definitions	6 week follow up
Secondary	Number of patients with life-threatening, disabling or major bleeding	Life-threatening, disabling or major bleeding complications according to the BARC definitions	6 week follow up