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NCT05319171 Clinical Trial

Performance of Currently Available traNscaTHEter Aortic Valve Platforms in Inoperable Patients With Pure Aortic regurgitatiON of a Native Valve. The PANTHEON International Project.

Aortic Regurgitation Clinical Trial

— PANTHEON  

Official title:
Performance of Currently Available traNscaTHEter Aortic Valve Platforms in Inoperable Patients With Pure Aortic regurgitatiON of a Native Valve. The PANTHEON International Project.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05319171
Other study ID # 12345
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2022
Est. completion date November 2022

Study information
Verified date March 2022
Source IRCCS Policlinico S. Donato
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

- To investigate the performance of currently available THVs in terms of safety and efficacy - To evaluate potential predictors of THV embolization or migration (TVEM) - To assess the impact of TVEM on prognosis

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date November 2022
Est. primary completion date October 2022
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - severe aortic regurgitation - prohibitive surgical risk Exclusion Criteria: - surgical candidates

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• TAVR
TAVR

Locations
Country Name City State
Italy IRCCS Policlinico S. Donato, Milan, Italy Milano Milan

Sponsors (1)
Lead Sponsor Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall mortality 1 year
See also
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