Risk Stratification Post TAVI Using TEG

NCT03649594 | Unknown

• 1 other identifier: RISTRATAVI-1-2019
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Global TEG(R)-based prediction of hypoattenuating leaflet thickening (HALT)

  TEG(R)readout Global Hemostasis Assay

  6 months

• Platelet TEG(R)-based prediction of hypoattenuating leaflet thickening (HALT)

  TEG(R)readout Platelet Mapping Assay

  6 months

Secondary Outcomes (4)

• All-cause mortality within 12 months

  12 months

• Cardiovascular mortality within 12 months

  12 months

• Thromboembolic events within 12 months

  12 months

• Bleeding events within 12 months

  12 months

Other Outcomes (1)

• Incidence of hypoattenuating leaflet thickening (HALT)

  6 months

Study Arms (2)

TAVI and no therapeutic anticoagulation

Subjects in this group do not have an indication for therapeutic anticoagulation.

TAVI and therapeutic anticoagulation

Subjects in this group have an indication for therapeutic anticoagulation such as atrial fibrillation.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients that are scheduled for TAVI using a commercially available valve after clinical decision making within the local Heart Team will be possible subjects yielding the eligibility criteria.

You may qualify if:

• \- Patients are eligible for enrollment if they are scheduled for TAVI using a commercially available valve after clinical decision making within the local Heart Team.

You may not qualify if:

• Valve-in-valve TAVI and prior valve thrombosis
• Severely impaired renal function (e.g. creatinine clearance \< 30ml/min)
• poor CT imaging if the presence of HALT cannot be assessed.

Sponsors & Collaborators

• Torben Pottgiesser: lead

Study Sites (1)

Department of Cardiology and Angiology I, Heart Center Freiburg University

Freiburg im Breisgau, 79106, Germany

RECRUITING

Related Publications (14)

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MeSH Terms

Conditions

Cardiovascular Diseases; Aortic Valve Stenosis; Thrombosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Ventricular Outflow Obstruction; Embolism and Thrombosis; Vascular Diseases

Study Officials

• Torben Pottgiesser, MD

  Cardiology and Angiology I, Heart Center Freiburg University, Germany

  PRINCIPAL INVESTIGATOR

• Daniel Duerschmied, MD

  Cardiology and Angiology I, Heart Center Freiburg University, Germany

  STUDY DIRECTOR

Central Study Contacts

Torben Pottgiesser, MD

CONTACT

+49761270; torben.pottgiesser@uniklinik-freiburg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. (Assistant Professor)

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 28, 2018
• Study Start: October 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2023
• Last Updated: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)