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Heart valve study tests safer bleeding control after TAVI

NCT ID NCT05774691

Disease control Sponsor: St. Antonius Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether giving a drug called protamine to all patients after a minimally invasive heart valve replacement (TAVI) reduces bleeding complications compared to giving it only when needed. The trial involved 1000 adults with aortic valve stenosis. The goal was to see if routine protamine use lowers the risk of death or serious bleeding within 30 days after the procedure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

1,000 people

The number who actually took part.

Started

Nov 2023

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

allergic disease aortic valve stenosis Hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic valve stenosis

Contacts and locations

Locations

  • A.S.Z. Aalst

    Aalst, Belgium

  • Amsterdam University Medical Center

    Amsterdam, Netherlands

  • Leiden University Medical Center

    Leiden, South Holland, Netherlands

  • Maastricht UMC

    Maastricht, Limburg, Netherlands

  • St. Antonius Hospital

    Nieuwegein, Utrecht, Netherlands

  • University Hospitals Leuven

    Leuven, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.