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

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Antonius Hospital
• Collaborator: St. Antonius Research Fund
• Treatments: Calcium heparin; Heparin; Protamines

Criteria

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

• Pregnancy