Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding in Vivo Model of Valvular Heart Diseases
NCT ID: NCT03279029
Last Updated: 2023-08-14
Study Results
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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SUSPENDED
NA
15 participants
INTERVENTIONAL
2017-09-14
2023-08-08
Brief Summary
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Methods: Bridge-to-transplant patients with AVD post-LVAD implantation are included. Patients operated on for severe aortic regurgitation are included as control. Clinical and TTE data are compiled. Samples of aortic valve are collected at the time of the intervention. RNA-sequencing analysis is performed in LVAD patients and variations of gene expression are validated by real time qPCR in both. Blood sampling are performed pre-operatively and at one-month follow up to assess the plasma level of previously identified gene modulators. In-vitro studies exposing VICs and VECs to several mechanical stimuli are performed for validation.
Conclusion(s) Taking together, the in-vivo and in-vitro models would provide important information for the understanding of valve remodeling and disease. ECM gene modulators could represent pertinent molecular targets to stop the progression of AVD
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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patients with aortic valve disease (AVD).
blood samples
blood samples
biopsy
biopsy of aortic valve
patients with left ventricular assist device (LVAD
blood samples
blood samples
biopsy
biopsy of aortic valve
Interventions
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blood samples
blood samples
biopsy
biopsy of aortic valve
Eligibility Criteria
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Inclusion Criteria
* Patients with severe aortic surgical spring deficiency
* Major Patient
Exclusion Criteria
* Pregnant or nursing women
* Major under guardianship
* People in emergencies
* Persons not covered by the social security scheme
18 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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alexis THERON
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique Hopitaux De Marseille
Locations
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Assistance Publique Hopitaux de Marseille
Marseille, , France
Countries
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Other Identifiers
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2017-A00680-53
Identifier Type: OTHER
Identifier Source: secondary_id
2017-08
Identifier Type: -
Identifier Source: org_study_id
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