NCT04392492
Unknown
Not Applicable
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
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.
Investigators
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)
Study Sites (1)
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