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Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation (POPular ACE TAVI)

RECRUITINGPhase 4Sponsored by St. Antonius Hospital
Actively Recruiting
PhasePhase 4
SponsorSt. Antonius Hospital
Started2023-11-01
Est. completion2025-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05774691

Summary

Heparin reversal by protamine administration after transcatheter aortic valve implantation (TAVI) may reduce bleeding events. However, protamine can also cause life-threatening allergic reactions. High-quality evidence regarding the clinical safety and efficacy of routine protamine administration after TAVI is lacking. The aim of this clinical trial is to determine if routine protamine administration, compared with selective protamine administration, reduces the risk of all-cause mortality or clinically relevant bleeding within 30 days after transcatheter aortic valve implantation.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Aged \> 18 years
* Undergoing transfemoral TAVI with any commercially available transcatheter heart valve
* Provided written informed consent

Exclusion Criteria:

* Documented protamine allergy or anaphylaxis
* Recent PCI (\< 3 months before TAVI)
* Planned arterial access via surgical cut-down

Conditions2

Aortic Valve StenosisHeart Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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