A Phase 4 interventional study of early anticoagulation and late anticoagulation in Mitral Regurgitation, Atrial Fibrillation and Anticoagulation, sponsored by National Institute of Cardiology, Warsaw, Poland. Enrolling by invitation at 5 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by National Institute of Cardiology, Warsaw, Poland · Phase 4, Interventional, and Treatment
Among 26 studies in Mitral Valve Insufficiency with a site in Poland — 10 open to participants now, 11 under way, none of them phase 3. Mitral Valve Insufficiency · Poland.
Among the 26 studies in Mitral Valve Insufficiency with a site in Poland, this one is the 4th largest by planned enrollment of the 22 interventional ones, is one of 2 that started in 2022, is one of 2 in phase 4, reaches primary completion later than 7 of the 10 other live ones, and was the 22nd registered.
468 studies on the registry are indexed under Mitral Valve Insufficiency; 164 are open to participants now.
This study's planned enrollment of 410 is above the median of 68 across 279 interventional studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →10 of the 26 studies in Mitral Valve Insufficiency with a site in Poland are open now, in 12 countries. Each count lists the studies.
Of the 122 Mitral Valve Insufficiency studies recruiting now, 101 (83%) set no upper age limit and 6 (5%) stop at 75 or younger; 13 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →26 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2022.
Median enrollment 67 across the 22 interventional studies, 1,000 across the 4 observational. Of the 10 that completed or were terminated, 5 (50%) have results posted.
18 of 26 have an industry lead sponsor. The 10 most frequent:
National Institute of Cardiology, Warsaw, Poland is the lead sponsor of 54 studies on the registry; 12 are open to participants now.
National Institute of Cardiology, Warsaw, Poland has 1 study filed under Mitral Valve Insufficiency — fewer than ten, so there is no comparison to draw.
4 of the studies in Mitral Valve Insufficiency with a site in Poland that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04029363HighLife SASExpanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk | 2026-12-15 |
| NCT03142152Cardiac Dimensions, Inc.The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR | 2026-12-31 |
| NCT05305612National Institute of Cardiology, Warsaw, PolandOptimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions | 2027-01 |
| NCT06583876Bio Refine Ltd.Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study | 2027-04 |
Among the 26 studies in Mitral Valve Insufficiency with a site in Poland, from their registry updates:
The transcatheter edge to edge mitral valve repair (TEER) and left atrial appendage closure (LAAC) are the interventional cardiology procedures that require periprocedural anticoagulation with unfractionated heparin (UFH). The UFH is administered either before or immediately after transseptal puncture, at the discretion of the operator
The aim of the study is to establish the optimal timing of initiation of periprocedural anticoagulation in patients undergoing structural heart interventions requiring transseptal puncture (TEER and LAAC), Patients who undergo TEER implantation or LAAC procedure will be randomized to two groups:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Presence of cardiac implantable electronic devices (implantable cardioverter-defibrillator [ICD], permanent pacemaker, or cardiac resynchronization therapy [CRT] system) in the following situations:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The iv. bolus of UFH (100Units/kg) will be given after obtained femoral vein access and at least 5 minutes prior to the start of the TSP.
Other: early anticoagulation
The iv. bolus of UFH (100Units/kg) will be given immediately after TSP, defined as the introduction of transseptal sheath into the left atrium.
Other: late anticoagulation
Anticoagulation prior to transseptal puncture
Anticoagulation after transseptal puncture
1. MACCE 2. Intraprocedural fresh thrombus formation in the right or left atrium as assessed with periprocedural transsesophageal echocardiography 3. Occurrence of new ischemic lesions with diameter ≥4 mm in brain MR performed 2-5 days after procedure
Major adverse cardiac and cerebrovascular events (MACCE) will include: death (all-cause and cardiovascular), stroke, TIA, non-fatal myocardial infarction or peripheral embolization, within 30 days from the index procedure.
Time frame: Within 30 days from the index procedure
Moderate and severe bleeding complications (BARC 2-5) including cardiac tamponade requiring intervention during the index hospitalization
Time frame: during the hospitalization related to the index procedure but up to 30 days from randomization
Intraprocedural fresh thrombus formation in the right or left atrium as assessed with periprocedural transsesophageal echocardiography
Time frame: during index procedure
Occurrence of new ischemic brain lesion in the MR examination performed within 2-5 days post index procedure.
Time frame: within 2-5 days post index procedure
Major adverse cardiac and cerebrovascular events death (all-cause and cardiovascular), stroke, TIA, non-fatal myocardial infarction or peripheral embolization, within 30 days from the index procedure.
Time frame: within 30 days from index procedure
Plan to share: Yes — to be defined
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD sharing will be considered after study completion and publication of the results.
Access criteria: to be defined
Started Mar 2022 (actual). Primary completion is estimated for Jan 2027, 58 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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National Institute of Cardiology, Warsaw, Poland