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

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The study goal is to determine the clinical benefit of percutaneous catheter-based left atrial appendage (LAA) closure in patients with non-valvular atrial fibrillation (NVAF) at high risk of stroke (CHA2DS2-VASc Score ≥2) as well as high risk of bleeding as compared to best medical care (including a [non-vitamin K] oral anticoagulant [(N)OAC] when eligible).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Collaborators: Atrial Fibrillation Network; Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK); Stiftung Institut fuer Herzinfarktforschung
• Treatments: Apixaban; Aspirin; Clopidogrel; Dabigatran; Edoxaban; Phenprocoumon; Rivaroxaban; Warfarin

Criteria

Key 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):

1. HAS-BLED-Score ≥ 3

2. Prior intracranial/intraspinal bleed, intraocular bleed compromising vision (BARC: type 3c)

3. 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

4. Chronic kidney disease with eGFR 15-29 ml/min/1.73 m2

5. 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

Key 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.)