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OpenTrials
Completed

NCT Number: NCT04500964

Transcatheter Aortic Valve Replacement for Failed Transcatheter Aortic Valve

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

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Key information

Conditions

Failed Transcather Aortic Valve

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

TAVR

Device

Trancatheter aortic valve replacement

Primary outcomes

  1. Overall mortality

    Time frame: 1 year

    Overall mortality and Cardiovascular mortality at 1 year

Secondary outcomes

  1. VARC-3 Events

    Time frame: 1 year

    Cerebrovascular events, bleeding complications, periprocedural MI, conduction disturbances, BVF, procedural success, device success, AKI (all according to VARC-2).

Sponsors and collaborators

Lead sponsor

IRCCS Policlinico S. Donato

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 6, 2020
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.