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NCT05422170 Clinical Trial

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
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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