Biological Collection and Registry of Patients Who Will Have a TAVR (Transcatheter Aortic Valve Replacement) Intervention (BIO TAVI)

A sample of plasma and whole blood will be obtained at 4 time points (pre-procedural, early post-procedural, at hospital discharge and during an eventual visite at 3 or 6 months post-procedural). Test for platelet reactivity (LTA, light transmittance aggregometry and Elisa PRI, Platelet reactivity index), multimeric VWF (von Willebrand factor) and blood level of NET: neutrophil extracellular traps(flow cytometry and ELISA) analyses will be performed at the time of blood sampling. Aliquots of plasma will be stored and frozen for further analyses

Study Overview

• Status: Unknown
• Conditions: Transcatheter Aortic Valve Replacement

Detailed Description

There are two major objectives:

• To correlate changes in VWF, platelet reactivity and blood level of NET after TAVR with clinical outcomes
• To correlate changes in VWF, platelet reactivity and blood level of NET with antithrombotic regimens after TAVR (direct anticoagulants apixaban versus standard of care, ie Vitamin K antagonist or antiplatelet therapy).

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Hôpital Pitié Salpetrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient undergoing TAVR

Description

Inclusion Criteria:

• patient undergoing TAVR intervention
• agreement given

Exclusion Criteria:

• severe thrombopenia ( <40.10^9/L)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac Events	stroke/transient ischemic attack; acute coronary syndrome; hospitalization for cardiac insufficiency, cardiovascular or unexplained deaths will be collected at 12 month by phone contact with the patient or his/her relatives or his/her treating physician	12 months
Bleeding	Serious bleeding event (BLEED II or more) will be collected at 12 month by phone contact with the patient or his/her relatives or his/her treating physician	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean pressure transprosthetic gradient	value of the mean pressure transprosthetic gradient after TAVR procedure will be assessed by TTE (transthoracic echography) or TOE (transesophageal echography)	within ten days after valve replacement

Collaborators and Investigators

• Sponsor: Action, France

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (Estimate): June 24, 2016

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2015-A01832-47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided