Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions

Launched by NATIONAL INSTITUTE OF CARDIOLOGY, WARSAW, POLAND · Mar 28, 2022

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age above 18 years
• • 2. Planned TEER procedure or left atrial appendage closure
• • 3. The patient is willing to sign informed consent and comply will all study procedure
• Exclusion Criteria:
• • 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.
• • 2. Congenital or acquire bleeding disorders (i.e.diagnosed thrombophilia, bleeding diathesis, thrombocyopenia with platelet count \<50 thousand/ml, INR elevated \>1.5 in the last test prior to randomization)
• • 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)
• • 4. Last dose of new oral anticoagulant \< 48 hours prior to the procedure (assessed at randomization)
• • 5. Last dose of low molecular weight heparin \<12 hours prior to the procedure (assessed at randomization)
• • 6. Contraindications to MR imaging (i.e. claustrophobia, ferromagnetic intraocular foreign boddies, ferromagnetic metalic prostheses)
• 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 dependant (lack of escape rhytm \>30/min)
• • the device was implanted or exchanged within 6 weeks prior to the MR examination
• • device mulfunction 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.