Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation Compared to Medical Therapy (NCT03463317) | Clinical Trial Compass
CompletedPhase 4
Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation Compared to Medical Therapy
Germany912 participantsStarted 2018-02-28
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* 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 Criteria:
* Absolute contraindication to acetylsalicylic acid
* Comorbidities other than AF requiring chronic (N)OAC therapy, e.g. mechanical heart valve prosthesis…
What they're measuring
1
Primary endpoint (net clinical benefit)
Timeframe: After 3, 6, and 12 months. Twice a year until 24 months and once a year after 24 months.