UnknownNot Applicable

HEParin Antagonisation in Transcatheter Aortic Valve Implantation

Germany50 participantsStarted 2022-07-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary endpoint

Timeframe: Periprocedural

Trial details

NCT IDNCT05422170

SponsorDeutsches Herzzentrum Muenchen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-01-31

Contact for this trial

Patrick Mayr, MD

+498912180 mayrp@dhm.mhn.de

View on ClinicalTrials.gov More Aortic Valve Stenosis trials