Aortic Valve Stenosis
Conditions
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.
Interventions
Femoral access site closure using the MANTA closure device
Sponsors
Karolinska University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with major vascular complications | 6 week follow up | Major vascular access site complications according to the VARC-2 definitions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Sweden
Outcome results
None listed