Performance of Currently Available traNscaTHEter Aortic Valve Platforms in Inoperable Patients With Pure Aortic regurgitatiON of a Native Valve. The PANTHEON International Project.
PANTHEON
1 other identifier
observational
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2022
CompletedFirst Posted
Study publicly available on registry
April 8, 2022
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedApril 8, 2022
March 1, 2022
5 months
March 31, 2022
March 31, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Overall mortality
1 year
Interventions
TAVR
Eligibility Criteria
inoperable patients with severe aortic regurgitation
You may qualify if:
- severe aortic regurgitation
- prohibitive surgical risk
You may not qualify if:
- surgical candidates
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Policlinico S. Donato, Milan, Italy
Milan, Milan, 20097, Italy
Related Publications (1)
Poletti E, De Backer O, Scotti A, Costa G, Bruno F, Fiorina C, Buzzatti N, Latini A, Rudolph TK, van den Dorpel MMP, Brinkmann C, Patel KP, Panoulas V, Schofer J, Giordano A, Barbanti M, Regazzoli D, Taramasso M, Saia F, Baumbach A, Maisano F, Van Mieghem NM, Sondergaard L, Latib A, Amat Santos IJ, Bedogni F, Testa L. Transcatheter Aortic Valve Replacement for Pure Native Aortic Valve Regurgitation: The PANTHEON International Project. JACC Cardiovasc Interv. 2023 Aug 28;16(16):1974-1985. doi: 10.1016/j.jcin.2023.07.026.
PMID: 37648345DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Contract Professor of CArdiology
Study Record Dates
First Submitted
March 31, 2022
First Posted
April 8, 2022
Study Start
May 1, 2022
Primary Completion
October 1, 2022
Study Completion
November 1, 2022
Last Updated
April 8, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share