HEParin Antagonisation in Transcatheter Aortic Valve Implantation

Aortic Valve Stenosis Clinical Trial

— HepaTAVI  

Official title:

Heparin Influence on Anticoagulation and Perioperative Hemostasis During Transfemoral Transcatheter Aortic Valve Implantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05422170
• Other study ID #: GE IDE No. T00222
• Status: Not yet recruiting
• Start date: July 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: June 2022
• Source: Deutsches Herzzentrum Muenchen
• Contact: Patrick Mayr, MD
• Phone: +498912180
• Email: mayrp[@]dhm.mhn.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 1, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Transcatheter Aortic Valve Implantation

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint	Variability of the ROTEM CT(INTEM) after partial heparin reversal	Periprocedural