NCT03649594: RISTRATAVI

Risk Stratification Post TAVI Using TEG

Status unknown Last updated 1 December 2020

What this trial tests

trial in Platelet Function Tests in 100 participants. Status unknown.

Timeline

1 October 2020

Primary endpoint
30 April 2022

30 April 2023

Quick facts

Lead sponsor	Torben Pottgiesser
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	100
Start date	1 October 2020
Primary completion	30 April 2022
Estimated completion	30 April 2023
Sites	1 location across Germany

Conditions studied

• Platelet Function Tests — all drugs for Platelet Function Tests →
• Predictive Value of Tests — all drugs for Predictive Value of Tests →
• Thrombelastography — all drugs for Thrombelastography →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

Torben Pottgiesser

Who can join

50 and older, any sex, with Platelet Function Tests or Predictive Value of Tests. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Modified Thromboelastography for Peri-interventional Assessment of Platelet Function in Cardiology Patients: A Narrative Review.
   Hartmann J, Curzen N. · · 2023 · cited 6× · PMID 36252602 · DOI 10.1055/s-0042-1757545
2. Associations of biomarkers with hypoattenuated leaflet thickening after transcatheter aortic valve replacement.
   Hesselbarth D, D'Orazio M, Ciccarone G, Gjermeni D, et al · · 2026 · PMID 41630814 · DOI 10.1016/j.rpth.2025.103341
3. Fibrin clot strength is associated with increased risk of major adverse cardiac events after TAVR.
   Hesselbarth D, D'Orazio M, Ciccarone G, Gjermeni D, et al · · 2025 · PMID 41051422 · DOI 10.1007/s00392-025-02749-7