CClinicalTrials.gg
Sign In
Status unknownNCT05319171PANTHEONUpdated Apr 8, 2022

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

An observational study in Aortic Regurgitation, sponsored by IRCCS Policlinico S. Donato. Status unknown at 1 site in Italy. Per ClinicalTrials.gov, last updated 2022-04-08.

Sponsored by IRCCS Policlinico S. Donato · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
100
Sex
All
01

Study 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
02

Conditions studied

  • Aortic Regurgitation
03

In context

Aortic Valve Insufficiency

162 studies on the registry are indexed under Aortic Valve Insufficiency; 52 are open to participants now.

This study's planned enrollment of 100 is below the median of 216 across 70 observational studies indexed under Aortic Valve Insufficiency.

Browse Aortic Valve Insufficiency studies →

Lead sponsor

IRCCS Policlinico S. Donato is the lead sponsor of 101 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

inoperable patients with severe aortic regurgitation

Inclusion criteria

  • severe aortic regurgitation
  • prohibitive surgical risk

Exclusion criteria

Exclusion Criteria:

  • surgical candidates
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
100 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Interventions

  • DeviceTAVR

    TAVR

06

What researchers measure

Primary outcomes

  1. Overall mortality

    Time frame: 1 year

07

Study locations

1 site
  • IRCCS Policlinico S. Donato, Milan, Italy
    Milano, Milan 20097, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05319171
Lead sponsor
IRCCS Policlinico S. Donato
Responsible party
Luca Testa (MD, PhD, Contract Professor of CArdiology, IRCCS Policlinico S. Donato) — Principal investigator
First posted
Apr 8, 2022
Start date
May 2022 (estimated)
Primary completion
Oct 2022 (estimated)
Completion
Nov 2022 (estimated)
Last update
Apr 8, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Aortic Valve Insufficiency→

Other studies from this sponsor

IRCCS Policlinico S. Donato

Start the discussion