Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding in Vivo Model of Valvular Heart Diseases
Primary Purpose
Aortic Valve Regurgitation Acquired
Status
Suspended
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
biopsy
Sponsored by
About this trial
This is an interventional other trial for Aortic Valve Regurgitation Acquired
Eligibility Criteria
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
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
patients with aortic valve disease (AVD).
patients with left ventricular assist device (LVAD
Arm Description
Outcomes
Primary Outcome Measures
blood sample
RNA-sequencing analysis
Secondary Outcome Measures
Full Information
NCT ID
NCT03279029
First Posted
September 8, 2017
Last Updated
August 9, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT03279029
Brief Title
Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding in Vivo Model of Valvular Heart Diseases
Official Title
Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding in Vivo Model of Valvular Heart Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Suspended
Why Stopped
2 patients included only
Study Start Date
September 14, 2017 (Actual)
Primary Completion Date
September 14, 2018 (Actual)
Study Completion Date
August 8, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Regurgitation Acquired
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients with aortic valve disease (AVD).
Arm Type
Experimental
Arm Title
patients with left ventricular assist device (LVAD
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
blood samples
Intervention Description
blood samples
Intervention Type
Biological
Intervention Name(s)
biopsy
Intervention Description
biopsy of aortic valve
Primary Outcome Measure Information:
Title
blood sample
Description
RNA-sequencing analysis
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
alexis THERON
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Learn more about this trial
Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding in Vivo Model of Valvular Heart Diseases
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