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Transcatheter Aortic Valve Replacement for Failed Transcatheter Aortic Valve

Transcatheter Aortic Valve Replacement for Failed Transcatheter Aortic Valve. An International Registry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04500964
Enrollment
173
Registered
2020-08-06
Start date
2019-01-01
Completion date
2020-07-01
Last updated
2023-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failed Transcather Aortic Valve

Brief summary

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

Interventions

DEVICETAVR

Trancatheter aortic valve replacement

Sponsors

IRCCS Policlinico S. Donato
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with failed transcather aortic valve (stenotic, regurgitant, both) and indication to further transcatheter aortic valve replacement (TAVR).

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Overall mortality1 yearOverall mortality and Cardiovascular mortality at 1 year

Secondary

MeasureTime frameDescription
VARC-3 Events1 yearCerebrovascular events, bleeding complications, periprocedural MI, conduction disturbances, BVF, procedural success, device success, AKI (all according to VARC-2).

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026