Clinical Trials Logo
  1. Home
  2. Aortic Stenosis
  3. NCT03847948

Biological Factors Associated With Subclinical Valvular Thrombosis — START  

Aortic Stenosis Clinical Trial

Official title:
Evaluation of Biological Factors Associated With Subclinical Valvular Thrombosis in pAtients With Severe aoRtic Stenosis Undergoing TAVI: START Trial

Clinical Trial 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 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

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03847948
Study type Observational [Patient Registry]
Source Hospital San Carlos, Madrid
Contact
Status Recruiting
Phase
Start date June 1, 2018
Completion date March 31, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04310046 - Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial N/A
Completed NCT03332745 - Mechanism of Decompensation Evaluation - Aortic Stenosis
Recruiting NCT06008080 - Post-Market Clinical Follow Up Study With Navitor Valve
Recruiting NCT06055751 - Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
Active, not recruiting NCT04815785 - Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis N/A
Terminated NCT02202434 - Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement N/A
Recruiting NCT03029026 - The Role of Occult Cardiac Amyloid in the Elderly With Aortic Stenosis.
Active, not recruiting NCT02903420 - A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan) N/A
Completed NCT02629328 - CardioCel Tri-leaflet Repair Study N/A
Completed NCT02306226 - Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
Withdrawn NCT01648309 - Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation N/A
Completed NCT01676727 - ADVANCE Direct Aortic Study
Completed NCT01422044 - Risk Prediction in Aortic Stenosis N/A
Withdrawn NCT00774657 - Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography N/A
Terminated NCT00535899 - Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS) N/A
Terminated NCT05070130 - OpSens PRIME CLASS
Completed NCT03314857 - China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population N/A
Completed NCT04157920 - Impact of Predilatation Between Self-expanding Valves N/A
Enrolling by invitation NCT06212050 - Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
Recruiting NCT05893082 - Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR N/A