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

NCT ID: NCT05319171

Last Updated: 2022-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-31

Study Completion Date

2022-11-30

Brief Summary

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* 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

Detailed Description

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Conditions

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Aortic Regurgitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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TAVR

TAVR

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* severe aortic regurgitation
* prohibitive surgical risk

Exclusion Criteria

* surgical candidates
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Policlinico S. Donato

OTHER

Sponsor Role lead

Responsible Party

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Luca Testa

MD, PhD, Contract Professor of CArdiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Policlinico S. Donato, Milan, Italy

Milan, Milan, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 37648345 (View on PubMed)

Other Identifiers

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12345

Identifier Type: -

Identifier Source: org_study_id

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