Performance of Currently Available traNscaTHEter Aortic Valve Platforms in Inoperable Patients With Pure Aortic regurgitatiON of a Native Valve. The PANTHEON International Project.
Sponsor
IRCCS Policlinico S. Donato (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05319171
Collaborator
(none)
100
1
6
16.5
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
100 participants
Observational Model:
Cohort
Time Perspective:
Other
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.
Anticipated Study Start Date
:
May 1, 2022
Anticipated Primary Completion Date
:
Oct 1, 2022
Anticipated Study Completion Date
:
Nov 1, 2022
Outcome Measures
Primary Outcome Measures
- Overall mortality [1 year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
-
severe aortic regurgitation
-
prohibitive surgical risk
Exclusion Criteria:
- surgical candidates
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRCCS Policlinico S. Donato, Milan, Italy | Milano | Milan | Italy | 20097 |
Sponsors and Collaborators
- IRCCS Policlinico S. Donato
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Luca Testa,
MD, PhD, Contract Professor of CArdiology,
IRCCS Policlinico S. Donato
ClinicalTrials.gov Identifier:
NCT05319171
Other Study ID Numbers:
- 12345
First Posted:
Apr 8, 2022
Last Update Posted:
Apr 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: