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Risk Stratification Post TAVI Using TEG

NCT03649594 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-12-01

No results posted yet for this study

Summary

Transcatheter aortic valve implantation (TAVI) has become the standard of care in elderly patients at increased risk for surgical aortic valve replacement . However, the optimal antithrombotic strategy post TAVI is still unclear. Current European guidelines recommend dual antiplatelet therapy (DAPT) for 3 to 6 months.The prevalence of subclinical leaflet thrombosis after TAVI is 15% up to 40%, but its clinical long-term relevance is uncertain. Thromboelastography (TEG(R)) can be used as a point-of-care system evaluating a patient's individual hemostasis profile. For the detection of transcatheter valve thrombosis it may be superior to conventional platelet function testing because global hemostasis can be assessed in addition to platelet function. The investigators intend an observational trial recruiting patients undergoing TAVI under standard care. At defined time points the investigators will serially perform TEG(R) as well as further platelet function testing (multiple electrode aggregometry) and conventional coagulation testing. The primary objective is to find surrogate TEG-derived markers / models predicting the development of a subclinical leaflet thrombosis after TAVI under usual care. The secondary objective is to find TEG-derived markers / models identifying patients at an increased risk after TAVI (all-cause mortality, cardiovascular mortality, thromboembolic and bleeding events).

Conditions

  • Platelet Function Tests
  • Predictive Value of Tests
  • Thrombelastography
  • Cardiovascular Diseases
  • Aortic Valve Stenosis
  • Thrombosis
  • Transcatheter Aortic Valve Replacement

Sponsors & Collaborators

  • Torben Pottgiesser

    lead OTHER

Principal Investigators

  • Torben Pottgiesser, MD · Cardiology and Angiology I, Heart Center Freiburg University, Germany

  • Daniel Duerschmied, MD · Cardiology and Angiology I, Heart Center Freiburg University, Germany

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-04-30
Completion
2023-04-30

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03649594 on ClinicalTrials.gov