Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions

Prior treatment

• 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.
• Last dose of non-vitamin K antagonist oral anticoagulant (NOAC) \< 48 hours before the procedure, in patients receiving NOAC therapy.
• Last dose of low-molecular-weight heparin (LMWH) \< 12 hours before the procedure, in patients receiving LMWH therapy.
• Presence of contraindications to brain magnetic resonance imaging (e.g., claustrophobia, metallic implants/prostheses).

Other illness

• Any diagnosed, acquired, or congenital bleeding or coagulation disorders (e.g., diagnosed thrombophilia, bleeding diatheses).
• 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.

Lab values

• INR \> 1.5 within 24 hours prior to the procedure in patients chronically treated with vitamin K antagonists.

• Age ≥ 18 years on the day of signing the informed consent form.
• Planned treatment of mitral regurgitation using the TEER technique (MitraClip or Pascal system) or planned left atrial appendage closure (Watchman system or Amplatzer system).
• The participant expresses willingness to comply with the study protocol, in particular the protocol-defined follow-up visits.
• The participant is willing to provide written informed consent to participate in the study.