Status:
COMPLETED
Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation Compared to Medical Therapy
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Atrial Fibrillation Network
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 (...
Detailed Description
The individualized therapy with oral anticoagulants is considered to be an essential preventive therapy in patients with atrial fibrillation. The risk of stroke can be reduced by approximately 65%. Ho...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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 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)
- 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)
- 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
- 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.)
Key Trial Info
Start Date :
February 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
912 Patients enrolled
Trial Details
Trial ID
NCT03463317
Start Date
February 28 2018
End Date
November 30 2024
Last Update
December 12 2025
Active Locations (42)
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1
Charité Universitätsmedizin Berlin, Klinik für Kardiologie, Angiologie und Intensivmedizin, Deutsches Herzzentrum der Charité, Campus Benjamin Franklin (CBF)
Berlin, Germany, 12203
2
DRK-Kliniken Berlin Köpenick, Klinik für Innere Medizin - Schwerpunkt Kardiologie und Angiologie
Berlin, Germany, 12559
3
Deutsches Herzzentrum der Charité, Klinik für Kardiologie, Angiologie und Intensivmedizin, Campus Virchow-Klinikum
Berlin, Germany, 13353
4
Klinik für Kardiologie, Angiologie und Intensivmedizin, Deutsches Herzzentrum der Charité, Campus Virchow-Klinikum (CVK)
Berlin, Germany, 13353