Complex Percutaneous Pulmonary Vein Isolation Combined With Left Atrial Appendage Occluder Implantation for Patients With Cardiogenic Ischemic Stroke in the Course of Atrial Fibrillation — PILOS-AF  

Atrial Fibrillation Clinical Trial

Official title: Complex Percutaneous Pulmonary Vein Isolation Combined With Left Atrial Appendage Occluder Implantation for Patients With Cardiogenic Ischemic Stroke in the Course of Atrial Fibrillation - PILOS-AF

Status Not yet recruiting

Clinical Trial Summary

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 ischemic stroke and cardiovascular death.

The study will comprise 240 patients who were diagnosed with ischemic stroke within preceding 6-12 weeks, with confirmed paroxysmal or persistent AF and low-to-moderate psychomotor dysfunction in the course of cerebral incident, who completed early neurological rehabilitation and are characterized by high risk of ischemic stroke recurrence (CHA2DS2-VASc score ≥2 pts in men; ≥3 pts in women) and who received adequate oral anticoagulation therapy (NOAC/VKA) for ≥4 weeks. After exclusion of thrombus and potential anatomical contraindications to the procedure on transesophageal echocardiography, patients will be randomized in 1:1:1 ratio to study group treated with combined single-stage PVI + LAAO implantation during 3-day hospitalization and to control group subject to LAAO implantation or control group subject to chronic therapy with NOAC.

The duration of active enrollment phase will be 18 months. Subsequent follow-up phase will include scheduled outpatient visits (at 3, 12, 48 months) and phone call interview (at 6, 18, 24, 36 months) in order to evaluate the occurrence of clinical and safety endpoints, medical symptoms and signs, quality of life reflected by structured questionnaire, the presence of AF on 7-day Holter electrocardiography.

Follow-up visits will also include blood laboratory tests analysis, including biomarkers of heart failure and left atrial wall stress, as well as transthoracic echocardiography with tissue Doppler imaging and strain imaging. In addition, patients in study group and control group treated with LAAO will attend additional outpatient visit at 6 weeks in order to perform transesophageal echocardiography so as to confirm procedural success and allow for termination of chronic anticoagulation therapy. Co-primary composite endpoint will comprise cardiovascular death, ischemic stroke, transient ischemic attack, systemic arterial embolism and major non-procedural bleeding, including intracranial bleeding (non-inferiority). The current project was based on the preliminary results of nonrandomized studies, which delivered evidence for feasibility of combined single-stage PVI and percutaneous left atrial appendage closure and laid ground for future randomized controlled trials. It is expected that the proposed intervention will be non-inferior in terms of composite cerebrovascular events and superior in terms of major nonprocedural bleeding in comparison to chronic NOAC therapy.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

• NCT number: NCT06212674
• Study type: Interventional
• Source: Medical University of Silesia
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 31, 2024
• Completion date: August 31, 2029