Aortic Valve Regurgitation Acquired Clinical Trial
Official title:
Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding in Vivo Model of Valvular Heart Diseases
| Verified date | August 2023 |
| Source | Assistance Publique Hopitaux De Marseille |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Suspended |
| Enrollment | 15 |
| Est. completion date | August 8, 2023 |
| Est. primary completion date | September 14, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients with long-term left-ventricular assistance awaiting transplant - Patients with severe aortic surgical spring deficiency - Major Patient Exclusion Criteria: - Minor Patient - Pregnant or nursing women - Major under guardianship - People in emergencies - Persons not covered by the social security scheme |
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hopitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | blood sample | RNA-sequencing analysis | 24 months |