Status:
UNKNOWN
Biological Factors Associated With Subclinical Valvular Thrombosis
Lead Sponsor:
Hospital San Carlos, Madrid
Collaborating Sponsors:
FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
Instituto de Salud Carlos III
Conditions:
Aortic Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
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 whe...
Detailed Description
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 va...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2022
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT03847948
Start Date
June 1 2018
End Date
March 31 2022
Last Update
October 29 2021
Active Locations (2)
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1
Hospital Clinic
Barcelona, Spain
2
Hospital Clinico San Carlos
Madrid, Spain, 28040