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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Suspended

Conditions: Aortic Valve Regurgitation Acquired

Treatments: Biological: blood samples; Biological: biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03279029

2017-08

2017-A00680-53 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

patients with aortic valve disease (AVD).

Experimental group

Treatment:

Biological: biopsy

Biological: blood samples

patients with left ventricular assist device (LVAD

Experimental group

Treatment:

Biological: biopsy

Biological: blood samples