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
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | blood samples | blood samples |
| BIOLOGICAL | biopsy | biopsy 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.