Biological Factors Associated With Subclinical Valvular Thrombosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2022-03-31

Brief Summary

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A prospective, multicentric cohort study including 166 patients with symptomatic aortic stenosis treated with transcatheter aortic valve implantation (TAVI).

\- The main objective is to determine whether the high residual platelet reactivity rates in patients undergoing TAVI is associated with the occurrence of clinical and / or subclinical prosthetic valve thrombosis measured by echocardiography and multi-slice computerized tomography

Detailed Description

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For the purpose of the study, platelet reactivity will be measured with the commercial kit PLT VASP/P2Y12 at baseline, 1day and 3 months postprocedure.

Secondary objectives include: -Determine the variability of platelet aggregation measured at baseline before the procedure, 1-day post-procedure and at 3-6 and 1 year follow-up.

* To determine whether the pro-thrombotic inflammatory response measured by the CD14 + and CD16 + quantification observed after TAVI is associated with the appearance of prosthetic thrombosis.
* To evaluate the Correlation of Von Willebrand factor levels and distribution of Von Willebrand multimers with the appearance of prosthetic thrombosis at baseline before the procedure, 1-day post-procedure and at 3, 6 months follow-up and 1 year.
* To determine whether the residual platelet reactivity rates in patients undergoing TAVI are associated with the occurrence of clinical events, at baseline before the procedure, 1-day post-procedure and at 3,6 months follow-up and 1 year
* To evaluate the clinical factors associated with the appearance of early prosthetic thrombosis.

Conditions

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Aortic Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with severe symptomatic aortic stenosis who it was accepted to be treated with TAVI by a multidisciplinary team "Heat Team".
* TAVI was successfully implanted (according to Valve Academic Research Consortium II criteria) and are under treatment with double antiplatelet therapy.
* Signed informed consent to participate in this study.

Exclusion Criteria

* Age under 18 years and pregnant or of childbearing age.
* Acute Recent stroke recent \<14 days before TAVI.
* The patients with proven allergy to aspirin, clopidogrel
* Patients that after TAVI cannot undergo a double antiplatelet regimen for 6 months due to a new post-TAVI medical indication or are anticoagulated.
* Knowledge of pregnancy or lactation Thrombocytopenia (\<50,000 platelets U / L) well documented and clinically relevant.
* The patients with documented moderate or severe hepatic insufficiency
* Severe chronic renal insufficiency with creatinine clearance \<30 ml / min.
* The patients who can not attend the follow-up visits scheduled in the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Pilar Jimenez Quevedo

MD, PhD, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Clinic

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Hospital Clinico San Carlos

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Ander Regueiro, MD, PhD

Role: primary

Pilar Jimenez Quevedo, MD, PhD

Role: primary

Esther Bernado, Drs

Role: backup

Other Identifiers

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PI17/01685

Identifier Type: -

Identifier Source: org_study_id