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

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Brief Title

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

Official Title

Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation (TAVI) Platelet Activation in TAVI

Brief Summary

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

Detailed Description

      -  Background: TAVI has emerged as an alternative to surgical aortic valve replacement for
           patients with severe, symptomatic aortic stenosis (AS) and is expanding worldwide with
           more than 50,000 patients treated to date.

        -  Purpose Changes in haemostasis, particularly in platelet activation or reactivity
           before, during and after TAVI have never been studied. Valve replacement is known to
           alleviate von Willebrand factor abnormalities associated with AS. A potential
           improvement of platelet function could also occur after TAVI. Indeed, circulating
           platelets may be desensitized and under-reactive due to multiple passages through the
           stenotic valve and could recover normal reactivity after TAVI. Besides, TAVI presents a
           risk of major ischemic complications. The investigators can hypothesize the involvement
           of high reactive platelets in peri-procedural thrombotic or ischemic events. This study
           of the platelet activation kinetics will be performed by comparing several specific
           markers before and at various times after valve implantation.

        -  Primary outcome To 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 days 1 and 5±1 after the procedure.

        -  Study design and number of subjects: This is a prospective, monocentric, study. The test
           group includes up to 15 patients treated by transfemoral TAVI using a MedTronic
           CoreValve (MCV) prosthesis. Platelet activation will be studied before and after the
           procedure and compared to a reference established with an age-matched, aspirin-treated,
           atherosclerotic population (30 patients in the control group).

        -  Eligibility criteria:

             -  inclusion criteria: test group: patients with severe aortic stenosis and
                transfemoral TAVI with MCV aspirin treatment . Control group: age-matched patients
                with stable coronary artery disease treated by aspirin but without aortic stenosis.

             -  exclusion criteria: recent (1 month) acute coronary syndrome; treatment by anti
                platelet agents other than aspirin

        -  Procedures: Specific platelet activation markers, circulating platelet/monocytes
           aggregates, platelet reactivity and vWF will be assessed in peripheral venous blood
           before, 1 and 5 days after TAVI and in ascending aorta during the procedure.

Study Type

Interventional

Primary Outcome

the change of kinetics of platelet activation

Secondary Outcome

 Changes of platelet activation

Condition

Aortic Stenosis

Intervention

test

Study Arms / Comparison Groups

 test group
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

44

Start Date

May 2014

Completion Date

October 2015

Primary Completion Date

October 2015

Eligibility Criteria

        Inclusion Criteria:

          -  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)

        Exclusion Criteria:

          -  Test group:

               -  Acute coronary syndrome 1 month before inclusion

               -  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:

               -  Acute coronary syndrome 1 month before inclusion

               -  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

Gender

All

Ages

50 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Pierre SIE, MD PhD, ,

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT02504632

Organization ID

14 7078 03

Responsible Party

Sponsor

Study Sponsor

University Hospital, Toulouse

Collaborators

 Medtronic

Study Sponsor

Pierre SIE, MD PhD, Study Chair, University Hospital, Toulouse

Verification Date

March 2017