HEPARIN SODIUM for Mitral regurgitation | Atrial fibrillation

Inclusion criteria

• {"criterion_text":"- 1. Age above 18 years."}
• {"criterion_text":"- 2. Planned mitral TEER * or LAAC † procedure."}
• {"criterion_text":"- 3. Participant expresses willingness to adhere to the study protocol, especially as specified by the protocol for follow-up visits.."}
• {"criterion_text":"- 4. The patient is willing to sign informed consent"}

Exclusion criteria

• {"criterion_text":"- 1. Women who are pregnant or breastfeeding and those women of childbearing potential who do not agree to use at least two contraceptive measures (oral contraception, mechanical contraception, approved contraceptive implants, intrauterine device, tubal ligation). The criterion does not apply to women who have been postmenopausal for at least 2 years prior to study enrollment (defined as at least one year without menstrual periods) or underwent surgical sterilization procedure. All eligible women who are younger than 55 years must have negative pregnancy test within 24 hours prior to randomization."}
• {"criterion_text":"- 2. Congenital or acquired bleeding disorders (i.e., diagnosed thrombophilia, bleeding diathesis, thrombocytopenia with platelet count <50 thousand/ml, INR elevation >1.5 due to the liver disease)."}
• {"criterion_text":"- 3. INR >1.5 within 24 hours prior to the procedure in patients chronically treated with vitamin K antagonists (applies to the last INR value prior to randomization)."}
• {"criterion_text":"- 4. Last dose of new oral anticoagulant <48 hours prior to the procedure (assessed at randomization)."}
• {"criterion_text":"- 5. Last dose of low molecular weight heparin <12 hours prior to the procedure (assessed at randomization)."}
• {"criterion_text":"- 6. Contraindications to MR imaging (i.e., claustrophobia, ferromagnetic intraocular foreign bodies, ferromagnetic metallic prostheses)."}
• {"criterion_text":"- 7. Implanted cardiac devices for electrotherapy if: - device has epicardial leads. - left disconnected leads or non-functional or damaged devices device implanted within abdominal wall. - the patient is pacemaker dependent (lack of escape rhythm >30/min). - the device was implanted or exchanged within 6 weeks prior to the MR. examination - device malfunction identified during the control performed prior to the MR examination, that in the opinion of electrophysiologist team may impact the safety of MR imaging. - low voltage of the device battery: the battery on the examination day should have at least 20% of the voltage value between the nominal value and elective replacement indicator (ERI) value, or the expected battery life calculated by the device should equal or exceed one year."}

Primary endpoints

• {"endpoint_text":"- The primary efficacy endpoint is a composite of the following: 1 major adverse cardiac and cerebrovascular events (MACCE; death, stroke, transient ischemic attack [TIA], myocardial infarction, or peripheral embolization) within 30 days after procedure; 2 intraprocedural new thrombus formation in the right or left atrium as assessed with periprocedural TEE; or 3 occurrence of new ischemic lesions with diameter ≥4 mm on brain MRI performed 2 to 5 days after the procedure.","definition_or_measurement_approach":"Composite measured as: 1) MACCE events occurring within 30 days after procedure; 2) intraprocedural thrombus assessed by periprocedural transesophageal echocardiography (TEE); 3) new ischemic brain lesions ≥4 mm assessed by brain MRI performed 2–5 days post-procedure."}

Secondary endpoints

• {"endpoint_text":"- The secondary/efficacy safety endpoint: moderate or severe bleeding complications (BARC 2-5) including cardiac tamponade requiring intervention during the index hospitalization; 1 intraprocedural new thrombus formation in the right or left atrium as assessed by periprocedural TEE; 2 occurrence of new ischemic brain lesions on MRI performed within 2 to 5 days after the index procedure; or 3 MACCE (death, stroke, TIA, peripheral embolization, myocardial infarction) within 30 days from the index","definition_or_measurement_approach":"Measured using BARC bleeding classification (types 2–5) including tamponade requiring intervention during index hospitalization; intraprocedural thrombus by periprocedural TEE; new ischemic brain lesions on MRI within 2–5 days post-procedure; MACCE within 30 days from index procedure."}

Poland

Earliest CTIS Part Ii Submission Date

30-10-2024

Latest Decision Or Authorization Date

11-02-2026

Processing Time Days

469

Number Of Sites

6

Number Of Participants

410

Primary sponsor

Full Name

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland