Ended Phase III and phase IV (Integrated) Aortic stenosis

Routine versus selective protamine administration to reduce bleeding complications after transcatheter aortic valve implantation

EU CTIS ID: 2023-504205-36-00

What this study is testing

To determine if routine protamine administration, compared with selective protamine administration, reduces the risk of the composite endpoint of all-cause death or clinically relevant bleeding within 30 days after TAVI.

  • Phase III and phase IV (Integrated)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

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

You likely can't join if

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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.