Left atrial appendage CLOSURE in patients with Atrial Fibrillation at high risk of stroke and bleeding compared to medical therapy (CLOSURE-AF-DZHK16)

ID

NCT03463317

Status

Active

DZG

DZHK

Start date

02/28/2018

Parameters

Inclusion criteria
  • 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 (a-e): 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
Exclusion criteria
  • Absolute contraindication to acetylsalicylic acid Comorbidities other than AF requiring chronic (N)OAC therapy
  • e.g. mechanical heart valve prosthesis Symptomatic carotid disease (if not treated) Complex aortic atheroma with mobile plaque (Kronzon classification grade V) Heart transplant Active infection or active endocarditis or other infections resulting in bacteremia Cardiac tumor Severe liver failure (Child-Pugh class C or liver failure with coagulopathy) Severe renal failure (GFR <15 ml/min/1.73m2) 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 Subject with participation in another interventional clinical trial during this study or within 30 days before entry into this trial. Known terminating disease with life expectancy <1 year (including those with end-stage heart failure) 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 Acute heart failure within the last 30 days Cardiac intervention within the last 30 days Subjects with planned cardiac or non-cardiac surgery or intervention. (These subject can be included 30 days after such intervention / surgery.)