Earlier blood thinner may cut clot risk in heart procedures
NCT ID NCT05305612
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 410 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
5 sites. The list below names each one and where it is.
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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.
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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
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Górnośląskie Centrum Medyczne im. Leszka Gieca Śląskiego Uniwersytetu Medycznego
Katowice, Poland
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Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin, Poland
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Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-355, Poland
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Uniwersyteckie Centrum Kliniczne Gdański Uniwersytet Medyczny
Gdansk, 80-952, Poland
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Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, Poland
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Other studies related to the condition(s) this trial covers.
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- Stroke's hidden heart rhythm clue under investigation
- Suture device may get heart patients walking sooner after leg vein procedures
- Two ways to catch a hidden heart rhythm after stroke
- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?