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

Not Applicable

Suspended

• Conditions: Aortic Valve Regurgitation Acquired
• Interventions: Biological: blood samples; Biological: biopsy

• Registration Number: NCT03279029
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-08
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-12
• Study Start: 2017-09-14
• Primary Completion: 2018-09-14
• Status Verified: 2023-08
• Study Completion: 2023-08-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with aortic valve disease (AVD).	blood samples	-
patients with aortic valve disease (AVD).	biopsy	-
patients with left ventricular assist device (LVAD	blood samples	-
patients with left ventricular assist device (LVAD	biopsy	-

Primary Outcome Measures

Name	Time	Method
blood sample	24 months	RNA-sequencing analysis

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France