Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-03-11 @ 4:09 PM
Study NCT ID:
NCT02504632
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2015-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation
Sponsor:
University Hospital, Toulouse
Organization:
Study Overview
Official Title:
Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation (TAVI) Platelet Activation in TAVI
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: