Transcatheter Aortic Valve Replacement for Failed Transcatheter Aortic Valve

NCT ID: NCT04500964

Last Updated: 2023-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

173 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-07-01

Brief Summary

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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

Detailed Description

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Conditions

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Failed Transcather Aortic Valve

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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failed transcather aortic valve (Stenotic)

TAVR

Intervention Type DEVICE

Trancatheter aortic valve replacement

failed transcather aortic valve (Regurgitation)

TAVR

Intervention Type DEVICE

Trancatheter aortic valve replacement

failed transcather aortic valve (Regurgitation and stenotic))

TAVR

Intervention Type DEVICE

Trancatheter aortic valve replacement

Interventions

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TAVR

Trancatheter aortic valve replacement

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Policlinico S. Donato

OTHER

Sponsor Role lead

Responsible Party

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Luca Testa

Interventional Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Policlinico San Donato

San Donato Milanese, Milan, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 35966561 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34092097 (View on PubMed)

Other Identifiers

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TRANSIT

Identifier Type: -

Identifier Source: org_study_id

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