Transcatheter Aortic Valve Replacement for Failed Transcatheter Aortic Valve

NCT04500964 | Completed FDA Device

• 1 other identifier: TRANSIT
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 1

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

Conditions

Failed Transcather Aortic Valve

Outcome Measures

Primary Outcomes (1)

• Overall mortality

  Overall mortality and Cardiovascular mortality at 1 year

  1 year

Secondary Outcomes (1)

• VARC-3 Events

  1 year

Study Arms (3)

failed transcather aortic valve (Stenotic)

Device: TAVR

failed transcather aortic valve (Regurgitation)

Device: TAVR

failed transcather aortic valve (Regurgitation and stenotic))

Device: TAVR

Interventions

TAVR DEVICE

Trancatheter aortic valve replacement

failed transcather aortic valve (Regurgitation and stenotic)); failed transcather aortic valve (Regurgitation); failed transcather aortic valve (Stenotic)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with failed transcather aortic valve

You may qualify if:

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

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Location

Related Publications (2)

• 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.

  PMID: 35966561 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.

  PMID: 34092097 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiology

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 6, 2020
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: July 1, 2020
• Last Updated: October 17, 2023

Record last verified: 2023-10

Locations

IT (1)