Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation Compared to Medical Therapy

Prior treatment

• Subject with participation in another interventional clinical trial during this study or within 30 days before entry into this trial.

Other illness

• Comorbidities other than AF requiring chronic (N)OAC therapy, e.g. mechanical heart valve prosthesis
• Symptomatic carotid disease (if not treated)
• Heart transplant
• Active infection or symptoms suggestive of COVID-19 infection or active endocarditis or other infections resulting in bacteremia
• Cardiac tumor
• Severe liver failure (Child-Pugh class C or liver failure with coagulopathy)
• Known terminating disease with life expectancy \<1 year (including those with end-stage heart failure)
• Unstable/not fully recompensated acute heart failure corresponding to NYHA class III and/or IV
• Subjects with known antiphospholipid syndrome
• Subjects with planned cardiac or non-cardiac surgery or intervention. (These subject can be included 30 days after such intervention / surgery.)

Lab values

• Severe renal failure (GFR \<15 ml/min/1.73m2 or current requirement for dialysis defined as current, regular renal replacement therapy performed at least weekly including hemodialysis and peritoneal dialysis within the last 30 days)

Other

• Absolute contraindication to acetylsalicylic acid
• Complex aortic atheroma with mobile plaque (Kronzon classification grade V)
• Pregnancy or breastfeeding
• For female patients of reproductive potential: Unwilling to agree to use a highly effective method of contraception (Pearl index \<1) throughout the study period
• Subjects, who are committed to an institution due to binding official or court order
• Subject who is dependent on the Site, the Site Investigator, any sub- investigator, his/her representative and/or the sponsor
• Persons who are not proficient in the German language

• Signed written informed consent
• Documented atrial fibrillation (paroxysmal, persistent, long-standing persistent or permanent)
• CHA2DS2VASc-Score ≥2
• High risk of bleeding under oral anticoagulation or contraindication for (N)OAC therapy, in particular patients with at least one of the following conditions:
  • HAS-BLED-Score ≥3
  • Prior intracranial/intraspinal bleed, intraocular bleed compromising vision (BARC: type 3c)
  • Hemorrhagic/bleeding complication fulfilling BARC type 3a or 3b: gastrointestinal tract, genitourinary tract or respiratory tract bleeding, where the patient is considered to be at a persistently increased risk of bleeding, e.g. the cause of bleeding cannot be successfully eliminated
  • Chronic kidney disease with eGFR 15-29 ml/min/1.73 m2
  • Any recurrent bleeding making chronic anticoagulation not feasible
• Subject eligible for an LAA occluder device
• Age ≥18 years
• Willing and capable of providing informed consent, participating in all associated study activities
• negative SARS-CoV-2 PCR test (no longer than 48 hours prior to randomization in outpatients or not older than 14 days in continuously hospitalized patients without signs of COVID-19 infection) or negative SARS- CoV-2 rapid antigen test (no longer than 24 hours prior to randomization)