Transcatheter Aortic Valve Replacement for Failed Transcatheter Aortic Valve

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

Study Overview

• Status: Completed
• Conditions: Failed Transcather Aortic Valve
• Intervention / Treatment: Device: TAVR

• Study Type: Observational
• Enrollment (Actual): 173

Contacts and Locations

Study Locations

• Italy
  • Milan
    • San Donato Milanese, Milan, Italy, 20097
      • IRCCS Policlinico San Donato

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with failed transcather aortic valve

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
failed transcather aortic valve (Stenotic)	Device: TAVR; Trancatheter aortic valve replacement
failed transcather aortic valve (Regurgitation)	Device: TAVR; Trancatheter aortic valve replacement
failed transcather aortic valve (Regurgitation and stenotic))	Device: TAVR; Trancatheter aortic valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall mortality	Overall mortality and Cardiovascular mortality at 1 year	1 year

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Donato

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: TRANSIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No