Failed Transcather Aortic Valve Clinical Trial
Official title:
Transcatheter Aortic Valve Replacement for Failed Transcatheter Aortic Valve. An International Registry
| NCT number | NCT04500964 |
| Other study ID # | TRANSIT |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 1, 2019 |
| Est. completion date | July 1, 2020 |
| Verified date | October 2023 |
| Source | IRCCS Policlinico S. Donato |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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
| Status | Completed |
| Enrollment | 173 |
| Est. completion date | July 1, 2020 |
| Est. primary completion date | January 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients with failed transcather aortic valve (stenotic, regurgitant, both) and indication to further transcatheter aortic valve replacement (TAVR). Exclusion Criteria: - |
| Country | Name | City | State |
|---|---|---|---|
| Italy | IRCCS Policlinico San Donato | San Donato Milanese | Milan |
| Lead Sponsor | Collaborator |
|---|---|
| IRCCS Policlinico S. Donato |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall mortality | Overall mortality and Cardiovascular mortality at 1 year | 1 year | |
| Secondary | VARC-3 Events | Cerebrovascular events, bleeding complications, periprocedural MI, conduction disturbances, BVF, procedural success, device success, AKI (all according to VARC-2). | 1 year |