Condition: Ischemic Stroke · Atrial Fibrillation · Sponsor: Medical University of Silesia
The project is a multicenter, open-label, randomized medical experiment, which was designed to evaluate the efficacy and safety of single-stage pulmonary vein isolation (PVI) and implantation of left atrial appendage occluder (LAAO) in comparison with either isolated LAAO implantation or chronic therapy with non-vitamin K antagonists anticoagulants (NOAC) in patients with recent-onset ischemic stroke and atrial fibrillation (AF). Based on former randomized controlled trials, percutaneous implantation of LAAO was shown to be non-inferior to vitamin K antagonists (VKA), but according to guidelines the use of LAAO is recommended only in patients with absolute contraindication to chronic anticoagulation therapy. PVI constitutes an acknowledged rhythm control management strategy in patients with paroxysmal and persistent AF, which leads to symptomatic relief in about 60% of treated patients, however, its beneficial effect on long-term outcome was demonstrated only in patients with heart failure with reduced ejection fraction. The feasibility and compatibility of both interventions performed as a combined single-stage procedure are warranted by common vascular access via transseptal puncture, which may lead to reduction of procedural cost and shortened overall duration of both interventions. Taking into consideration the preliminary registry data, the combined single-stage PVI and LAAO implantation are thought to be a safe procedure in patients with a high risk of recurrent ischemi…
This description comes directly from the study's public registry record.
Maciej T. Wybraniec, MD, PhD, Professor · +48324796065 · mwybraniec@sum.edu.pl
Krystian Wita, MD, PhD, Professor · +48323598953 · dl@gcm.pl
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| Upper-Silesian Medical Center | Katowice, Upper Silesia, Poland | Recruiting |
| Silesian Center for Heart Disease | Zabrze, Upper Silesia, Poland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06212674