NCT03279029

Suspended

Aortic Valve Regurgitation Acquired After Left Ventricular A...

Assistance Publique Hopitaux De Marseille Source

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

2017-08

Secondary identifiers

2017-A00680-53

OTHER · idrcb

Study Type

interventional

Estimated enrollment

15

Locations

1 country

Sites

1

Timeline

Study Start

September 14, 2017

Actual (reported)

Primary Completion

September 14, 2018

Actual (reported)

Study Completion

August 8, 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: suspended
Estimated enrollment: 15 participants
Study completion date: August 8, 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
September 8, 2017
Actual (reported)
First Posted
September 12, 2017
Actual (reported)
Study Start
September 14, 2017
Actual (reported)
Primary Completion
September 14, 2018
Actual (reported)
Study Completion
August 8, 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: August 14, 2023
Status Verified: August 2023
Last Update Submitted: August 9, 2023

Conditions

Aortic Valve Regurgitation Acquired

Outcome Measures

Primary Outcomes (1)

blood sample
RNA-sequencing analysis
24 months

Study Arms (2)

patients with aortic valve disease (AVD).

EXPERIMENTAL

Biological: blood samplesBiological: biopsy

patients with left ventricular assist device (LVAD

EXPERIMENTAL

Biological: blood samplesBiological: biopsy

Interventions

blood samplesBiological

blood samples

patients with aortic valve disease (AVD).patients with left ventricular assist device (LVAD

biopsyBiological

biopsy of aortic valve

patients with aortic valve disease (AVD).

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients with long-term left-ventricular assistance awaiting transplant
Patients with severe aortic surgical spring deficiency

Sponsors & Collaborators

Assistance Publique Hopitaux De Marseille
Otherlead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

MeSH Terms

Interventions

Blood Specimen CollectionBiopsy

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesCytodiagnosisCytological TechniquesDiagnostic Techniques, Surgical

Study Officials

alexis THERON
Assistance Publique Hopitaux De Marseille
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 8, 2017

First Posted

September 12, 2017

Study Start

September 14, 2017

Actual (reported)

Primary Completion

September 14, 2018

Actual (reported)

Not Applicable

Completed

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patients with left ventricular assist device (LVAD

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Major Patient

You may not qualify if:

Minor Patient
Pregnant or nursing women
Major under guardianship
People in emergencies
Persons not covered by the social security scheme

Contact the study team to confirm eligibility.

Study Completion

August 8, 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

August 14, 2023

Record last verified: 2023-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03279029
Data provider: ClinicalTrials.gov
Source updated: 2023-08-14
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:20:18 UTC

Locations

FR(1)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

patients with aortic valve disease (AVD).

patients with left ventricular assist device (LVAD

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

patients with aortic valve disease (AVD).

patients with left ventricular assist device (LVAD

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations