HEParin Antagonisation in Transcatheter Aortic Valve Implantation (HepaTAVI)

German Heart Center Munich

Status: Not yet enrolling

Conditions: Transcatheter Aortic Valve Implantation; Aortic Valve Stenosis; Protamine Sulfate Overdose

Study type: Observational

Funder types: Other

Identifiers

NCT05422170

GE IDE No. T00222

Details and patient eligibility

About

Unfractioned heparin is usually given in a defined dosage during transfemoral TAVI. Activated Clotting Time (ACT) is usually used to measure the heparin effect. ACT-analysis is easy to perform at the bedside, but susceptible to interference effects. At the end of the procedure, protamine is given to reverse eventual residual heparin effect. An overdose of protamine can impair the coagulation itself. The investigators want to analyse the effect of a partial heparin reversal by ROTEM Analysis.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe aortic valve Stenosis
• transfemoral TAVI as best therapy option
• unfractioned heparin for periprocedural anticoagulation

Exclusion criteria

• known hypersensitivity /allergy to unfractioned heparin or protamine
• acute systemic infection
• pre procedural started and ongoing intravenous therapy with unfractioned heparin
• severe periprocedural adverse event with the need for emergency surgery (with or with our CPB)
• refusal of the patient to participate

Trial design

50 participants in 1 patient group

Patients undergoing transfemoral TAVI

Description:

Patients receiving 125 U/kg unfractioned heparin for periprocedural anticoagulation and 500U Protamine / 1000U Heparin at the end of the procedure