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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing transfemoral TAVI with MANTA closure | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MANTA vascular closure device | Device | Femoral access site closure using the MANTA closure device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with major vascular complications | Major vascular access site complications according to the VARC-2 definitions | 6 week follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with minor vascular complications | Minor vascular access site complications according to the VARC-2 definitions | 6 week follow up |
| Number of patients with vascular closure device failure |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients undergoing TAVI at the Karolinska University Hospital
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Karolinska University Hospital | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35427700 | Derived | Kastengren M, Settergren M, Ruck A, Feldt K, Saleh N, Linder R, Verouhis D, Meduri CU, Bager J, Dalen M. Percutaneous plug-based vascular closure device in 1000 consecutive transfemoral transcatheter aortic valve implantations. Int J Cardiol. 2022 Jul 15;359:7-13. doi: 10.1016/j.ijcard.2022.04.033. Epub 2022 Apr 12. |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Percutaneous vascular closure device failure according to the VARC-2 definitions
| 6 week follow up |
| 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 |
| D014694 |
| Ventricular Outflow Obstruction |