Earlier blood thinner may cut clot risk in heart procedures

NCT ID NCT05305612

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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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers compare two timings for giving the blood thinner heparin during minimally invasive heart procedures that require a puncture through the wall between the heart's upper chambers. Adults scheduled for mitral valve repair or left atrial appendage closure join the trial. One group receives heparin before the puncture, the other right after. The study tracks strokes, clots, and bleeding to learn which timing is safer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
unfractionated heparin, a blood thinner given intravenously
What this could lead to
If one timing works better, doctors could standardize when they give heparin during these heart procedures, potentially reducing strokes and clots.
What could go wrong
The trial may show no clear difference between the two timings, or the results might not apply to all patients or centers. Bleeding and clotting remain risks of the procedures themselves.

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

About 410 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Mar 2027

An estimate. End dates often move.

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: 1. Age ≥ 18 years on the day of signing the informed consent form. 2. Planned treatment of mitral regurgitation using the TEER technique (MitraClip or Pascal system) or planned left atrial appendage closure (Watchman system or Amplatzer system). 3. The participant expresses willingness to comply with the study protocol, in particular the protocol-defined follow-up visits. 4. The participant is willing to provide written informed consent to participate in the study. Exclusion Criteria: 1. Pregnant or lactating women, and women of childbearing potential who do not agree to use at least two methods of contraception (oral contraceptives, barrier methods, approved contraceptive implants, injectable depot contraceptives, intrauterine devices, or tubal ligation). This does not apply to women who are postmenopausal (≥ 1 year from last menses) for ≥ 2 years AND, if \< 55 years old, have a negative pregnancy test within 24 hours prior to randomization, or have undergone surgical sterilization. 2. Any diagnosed, acquired, or congenital bleeding or coagulation disorders (e.g., diagnosed thrombophilia, bleeding diatheses). 3. INR \> 1.5 within 24 hours prior to the procedure in patients chronically treated with vitamin K antagonists. 4. Last dose of non-vitamin K antagonist oral anticoagulant (NOAC) \< 48 hours before the procedure, in patients receiving NOAC therapy. 5. Last dose of low-molecular-weight heparin (LMWH) \< 12 hours before the procedure, in patients receiving LMWH therapy. 6. Presence of contraindications to brain magnetic resonance imaging (e.g., claustrophobia, metallic implants/prostheses). 7. Presence of cardiac implantable electronic devices (implantable cardioverter-defibrillator \[ICD\], permanent pacemaker, or cardiac resynchronization therapy \[CRT\] system) in the following situations: * Epicardial leads * Left disconnected leads or non-functional or damaged devices * Devices implanted within abdominal wall * Pacemaker dependent patients (Lack of escape rhythm \> 30 bpm). * Patients in whom less than 6 weeks have elapsed since system implantation or replacement. * Patients in whom pre-MRI system interrogation reveals abnormalities in system function or cardiac arrhythmias that, in the opinion of the supervising electrophysiology team, could compromise MRI safety. * Patients whose device battery on the day of the MRI examination has less than 20% voltage between nominal and ERI, or the projected device longevity is less than 1 year.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Górnośląskie Centrum Medyczne im. Leszka Gieca Śląskiego Uniwersytetu Medycznego

    Katowice, Poland

  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

    Lublin, Poland

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-355, Poland

  • Uniwersyteckie Centrum Kliniczne Gdański Uniwersytet Medyczny

    Gdansk, 80-952, Poland

  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

    Warsaw, Poland

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