Clinical Trials Directory

Trials / Suspended

SuspendedNCT03279029

Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding in Vivo Model of Valvular Heart Diseases

Status
Suspended
Phase
N/A
Study type
Interventional
Enrollment
15 (estimated)
Sponsor
Assistance Publique Hopitaux De Marseille · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

To investigate histological structure and molecular changes involved on the onset of AVD after left ventricular assist device (LVAD) implantation and to compare them with those of patients operated on for severe aortic regurgitation. 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

Conditions

Interventions

TypeNameDescription
BIOLOGICALblood samplesblood samples
BIOLOGICALbiopsybiopsy of aortic valve

Timeline

Start date
2017-09-14
Primary completion
2018-09-14
Completion
2023-08-08
First posted
2017-09-12
Last updated
2023-08-14

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03279029. Inclusion in this directory is not an endorsement.