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Patients with failed transcather aortic valve (stenotic, regurgitant, both) and indication to further transcatheter aortic valve replacement (TAVR).
The purpouse of this study is to evaluate the indication to a second TAVR, the selection criteria of the second transcatheter aortic valve, procedural and clinical outcomes.
The primary endpoint of the study is overall mortality and Cardiovascular mortality at 1 year
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| failed transcather aortic valve (Stenotic) |
| ||
| failed transcather aortic valve (Regurgitation) |
| ||
| failed transcather aortic valve (Regurgitation and stenotic)) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAVR | Device | Trancatheter aortic valve replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall mortality | Overall mortality and Cardiovascular mortality at 1 year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| VARC-3 Events | Cerebrovascular events, bleeding complications, periprocedural MI, conduction disturbances, BVF, procedural success, device success, AKI (all according to VARC-2). | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
-
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Patients with failed transcather aortic valve
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Policlinico San Donato | San Donato Milanese | Milan | 20097 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35966561 | Derived | Testa L, Casenghi M, Criscione E, Van Mieghem NM, Tchetche D, Asgar AW, De Backer O, Latib A, Reimers B, Stefanini G, Trani C, Giannini F, Bartorelli A, Wojakowski W, Dabrowski M, Jagielak D, Banning AP, Kharbanda R, Moreno R, Schofer J, Brinkmann C, van Royen N, Pinto D, Serra A, Segev A, Giordano A, Brambilla N, Agnifili M, Rubbio AP, Squillace M, Oreglia J, Tanja R, McCabe JM, Abizaid A, Voskuil M, Teles R, Zoccai GB, Sondergaard L, Bedogni F. Prosthesis-patient mismatch following transcatheter aortic valve replacement for degenerated transcatheter aortic valves: the TRANSIT-PPM international project. Front Cardiovasc Med. 2022 Jul 29;9:931207. doi: 10.3389/fcvm.2022.931207. eCollection 2022. | |
| 34092097 |
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| Derived |
| Testa L, Agnifili M, Van Mieghem NM, Tchetche D, Asgar AW, De Backer O, Latib A, Reimers B, Stefanini G, Trani C, Colombo A, Giannini F, Bartorelli A, Wojakowski W, Dabrowski M, Jagielak D, Banning AP, Kharbanda R, Moreno R, Schofer J, van Royen N, Pinto D, Serra A, Segev A, Giordano A, Brambilla N, Popolo Rubbio A, Casenghi M, Oreglia J, De Marco F, Tanja R, McCabe JM, Abizaid A, Voskuil M, Teles R, Biondi Zoccai G, Bianchi G, Sondergaard L, Bedogni F. Transcatheter Aortic Valve Replacement for Degenerated Transcatheter Aortic Valves: The TRANSIT International Project. Circ Cardiovasc Interv. 2021 Jun;14(6):e010440. doi: 10.1161/CIRCINTERVENTIONS.120.010440. Epub 2021 Jun 7. |