Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation

NCT02504632 | Completed

• 1 other identifier: 14 7078 03
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Study of platelet activation by severe aortic stenosis and its correction by Transcatheter Aortic Valve Implantation (TAVI)

Conditions

Aortic Stenosis

Keywords

platelet activation; transcatheter aortic valve implantation

Outcome Measures

Primary Outcomes (2)

• the change of kinetics of platelet activation

  Evaluate the kinetics of platelet activation before and at various times after valve implantation, by comparing several specific markers in peripheral venous blood samples before (day 0) and at day 1 after the procedure using flow cytometry (FACS).

  1 min before TAVI and at days 1after TAVI

• the change of kinetics of platelet activation

  Evaluate the kinetics of platelet activation before and at various times after valve implantation, by comparing several specific markers in peripheral venous blood samples before (day 0) and at 5±1 days after the procedure using flow cytometry (FACS).

  1 min before TAVI and 5±1 after TAVI

Secondary Outcomes (4)

• Changes of platelet activation

  1 min before and 10 min after TAVI

• Changes of platelet activity

  1 min before and day 1 after TAVI

• Changes of platelet activity

  1 min before and day 5 after TAVI

• changes in von Willebrand factor

  1 min before and day 1 and 5 after TAVI

Study Arms (2)

test group

EXPERIMENTAL

Patient with severe, symptomatic AS (Aortic valve area \< 0,6 cm2/m2 SC), deemed, after multidisciplinary heart team evaluation, contra-indicated or at high risk for surgery and suitable for TF TAVI with a MCV prosthesis.

Other: test

control group

OTHER

Patient with stable coronary artery disease, unscathed of AS Patient under aspirin treatment (75-160 mg/d for at least one week)

Other: control group

Interventions

test OTHER

Peripheral venous citrated blood will be collected just before and 10-15 min after the implantation of the valve. Samples will be obtained after starting the infusion of contrast media. In peripheral venous blood before 24 h and after the procedure and at hospital discharge, 4-6 days when the usual transient thrombocytopenia after TAVI has recovered. The results will be used to analyse the kinetics of haematological changes in peripheral blood following aortic valve replacement. Platelet activation will be monitored by flow cytometry to assess the expression of specific membrane markers and the phosphorylation of signalling proteins, as well as the formation of platelet/monocyte aggregates.

test group

control group OTHER

In this group, only one sample (2 tubes filled with 4.5 ml, i.e. 9ml) will be obtained in venous peripheral blood to establish reference values in age-matched, aspirin-treated, atherosclerotic population.

control group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Test group
• Severe symptomatic AS (Aortic valve area \< 0,6 cm2/m2 SC), deemed, after multidisciplinary heart team evaluation, contra-indicated or at high risk for surgery and suitable for TF TAVI with a MCV prosthesis.
• Aspirin treatment (75-160 mg/d for at least one week)
• Control group
• Stable coronary artery disease, unscathed of AS
• Aspirin treatment (75-160 mg/d for at least one week)

You may not qualify if:

• Test group:
• Any co-morbidity limiting life-expectancy \< 1 year
• Terminal chronic kidney disease requiring hemodialysis thrombocytopenia \<100 G/L, anemia (Hb \< 10 g/dl)
• Treatment by another antiplatelet agent within 10 days before the procedure
• Control group:
• Any co-morbidity limiting life-expectancy \< 1 year
• Terminal chronic kidney disease requiring hemodialysis
• Thrombocytopenia \<100 G/L
• Treatment by another antiplatelet agent within 10 days before the procedure

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Medtronic: collaborator

Study Sites (1)

CHU TOULOUSE-Hôpital Rangueil

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Pierre SIE, MD PhD

  University Hospital, Toulouse

  STUDY CHAIR

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: July 17, 2015
• First Posted: July 22, 2015
• Study Start: May 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 14, 2017

Record last verified: 2017-03

Locations

FR (1)