Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation (POPular ACE TAVI) - Trial NCT05774691
Access comprehensive clinical trial information for NCT05774691 through Pure Global AI's free database. This Phase 4 trial is sponsored by St. Antonius Hospital and is currently Not yet recruiting. The study focuses on Aortic Valve Stenosis. Target enrollment is 1000 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
St. Antonius Hospital
Timeline & Enrollment
Phase 4
Jun 01, 2023
Dec 31, 2025
Primary Outcome
Composite of cardiovascular mortality or type 1-4 bleeding
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 cardiovascular mortality or
 bleeding within 30 days after transcatheter aortic valve implantation.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05774691
Non-Device Trial