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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Single-stage Pulmonary Vein Isolation Combined With Percutaneous Left Atrial Appendage Occluder Implantation in Patients With Recent Onset Ischemic Stroke and Atrial Fibrillation

Single-stage Pulmonary Vein Isolation Combined With Percutaneous Left Atrial Appendage Occluder Implantation in Patients With Recent Onset Ischemic Stroke and Atrial Fibrillation (PILOS-AF)

Single-stage Pulmonary Vein Isolation Combined With Percutaneous Left Atrial Appendage Occluder Implantation in Patients With Recent Onset Ischemic Stroke and Atrial Fibrillation (NCT06212674) is a Phase 4 interventional studying Ischemic Stroke and Atrial Fibrillation, sponsored by Medical University of Silesia. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 2-12 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-VA score ≥2 pts) 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 A treated with combined single-stage PVI + LAAO implantation during 3-day hospitalization or to group B treated with LAAO implantation or control group subject to chronic therapy with NOAC. Patients in Group A and B will be treated with NOAC until 3 months after procedure. At 3-month visit patients in Group A and B will undergo transesophageal echocardiography so as to confirm procedural success and allow for termination of chronic anticoagulation therapy. If device-related thrombus is excluded and not peri-device leak \>=5 mm is present, the patients will be switched from NOAC to aspirin 1x75 mg daily until the end of the trial. The duration of active enrollment phase will be 12 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 24, 7-day or 30-day ECG monitoring (at 12 and 48 months). 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. 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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 240 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Ischemic Stroke subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Ischemic stroke within 2-12 weeks after randomization with or without reperfusion therapy, confirmed by imaging studies (CT or MRI) that led to mild to moderate psychomotor dysfunction (mRS 0-3; NIHSS \<16 points) and was treated with early neurological rehabilitation or was exempt from neurological rehabilitation on account of excellent psychomotor function. An obligatory criterion is persistence of symptoms for \>24 h. 2. Diagnosis of paroxysmal or persistent atrial fibrillation on the basis of 12-lead ECG recording, ECG Holter monitoring, event-recorder or loop recorder at any time, but before the screening visit. 3. CHA2DS2-VA risk score ≥2 points 4. Left atrial anatomy (atrial septum, pulmonary vein orifices and left atrial appendage) suitable for intervention (PVI + LAAO or LAAO) 5. ≥ 4 weeks of adequate anticoagulant treatment in the preceding period 6. no anatomical or functional contraindications and patient consent for transesophageal echocardiography (TEE) Based on the aforementioned inclusion criteria, patients who can be classified into 3. groups will be enrolled in the study: 1. patients with atrial fibrillation who have been adequately treated with anticoagulation (VKA/NOAC) and have had an ischemic stroke 2. patients without prior history of atrial fibrillation and without anticoagulation who have an ischemic stroke and the atrial fibrillation is clinically overt (de novo) 3. patients without a prior history of atrial fibrillation, with an initial diagnosis of so-called cryptogenic stroke, in whom further initial ECG monitoring allowed for the detection of clinically silent atrial fibrillation Who Should NOT Join This Trial: - current participation in another clinical trial - lack of informed written consent to participate in the study - age \<18 or \>80 years - indication for chronic anticoagulant treatment independent of AF: 1. history of mechanical valve implantation ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Ischemic stroke within 2-12 weeks after randomization with or without reperfusion therapy, confirmed by imaging studies (CT or MRI) that led to mild to moderate psychomotor dysfunction (mRS 0-3; NIHSS \<16 points) and was treated with early neurological rehabilitation or was exempt from neurological rehabilitation on account of excellent psychomotor function. An obligatory criterion is persistence of symptoms for \>24 h. 2. Diagnosis of paroxysmal or persistent atrial fibrillation on the basis of 12-lead ECG recording, ECG Holter monitoring, event-recorder or loop recorder at any time, but before the screening visit. 3. CHA2DS2-VA risk score ≥2 points 4. Left atrial anatomy (atrial septum, pulmonary vein orifices and left atrial appendage) suitable for intervention (PVI + LAAO or LAAO) 5. ≥ 4 weeks of adequate anticoagulant treatment in the preceding period 6. no anatomical or functional contraindications and patient consent for transesophageal echocardiography (TEE) Based on the aforementioned inclusion criteria, patients who can be classified into 3. groups will be enrolled in the study: 1. patients with atrial fibrillation who have been adequately treated with anticoagulation (VKA/NOAC) and have had an ischemic stroke 2. patients without prior history of atrial fibrillation and without anticoagulation who have an ischemic stroke and the atrial fibrillation is clinically overt (de novo) 3. patients without a prior history of atrial fibrillation, with an initial diagnosis of so-called cryptogenic stroke, in whom further initial ECG monitoring allowed for the detection of clinically silent atrial fibrillation Exclusion Criteria: * current participation in another clinical trial * lack of informed written consent to participate in the study * age \<18 or \>80 years * indication for chronic anticoagulant treatment independent of AF: 1. history of mechanical valve implantation 2. history of mitral biological valve implantation within 3 months prior to randomization 3. history of deep vein thrombosis or pulmonary embolism within preceding 6 months or indication for chronic anticoagulation 4. genetically or immunologically confirmed thrombophilia * contraindications to NOAC treatment: 1. eGFR ≤15 ml/min/1.73 m2 2. mechanical valve prosthesis 3. moderate or severe mitral valve stenosis of rheumatic etiology 4. life-threatening bleeding during NOAC therapy * Ischemic stroke of etiology other than AF, including cryptogenic stroke without evidence of AF etiology * valvular AF: presence of moderate to severe aortic stenosis of rheumatic etiology * permanent AF * persistent long-standing AF (\>1 year) * presence of a thrombus in the left atrial appendage on TEE examination * significant psychomotor dysfunction defined as a modified Rankin Scale (mRS) score of 4-6 or NIHSS score ≥16 * major bleeding as defined by ISTH within 14 days prior to randomization or intracranial bleeding ever * active hyperthyroidism * history of myocardial infarction with or without intervention within 90 days prior to randomization * history of PVI or LAAO implantation * history of surgical closure of left atrial appendage * history of percutaneous or surgical ASD/PFO closure * acute or chronic pericarditis * cardiac tamponade * lack of vascular access for PVI and LAAO implantation * chronic heart failure in NYHA functional class IV * left ventricular ejection fraction (LVEF) \<30% * chronic kidney disease stage IV-V (eGFR \<30 ml/min/1.73 m2) * Child-Pugh class B or C chronic liver failure * severe valvular heart defect * body mass index (BMI, body mass index) ≥40 kg/m2 * woman in her childbearing years planning a pregnancy * pregnancy or lactation period * documented life expectancy \< 4 years * active cancer \< 5 years after remission * active infection, defined as CRP \>30 mg/dL with symptoms of respiratory, urinary or gastrointestinal tract infection

Treatments Being Tested

PROCEDURE

PVI + LAAO, single stage

Treatment with a complex procedure of pulmonary vein isolation (PVI) and left atrial appendage occludder implantation (LAAO) via single transseptal puncture within 4 weeks from randomization. PVI will be performed only by means of radiofrequency (RF) ablation. Other types of PVI will not be allowed (cryoballoon or pulsed field ablation). LAAO implantation will comprise the use of either Amplatzer™ Amulet™ (Abbott) or WATCHMAN FLX™ (Boston Scientific) depending on local center's expertise. The procedure will be carried out within 4 weeks from randomization and will be performed during 3-day hospitalization in cardiology department. The procedure will be preceded by at least 4-week adequate anticoagulation with non-vitamin K antagonists (NOAC). The last dose of NOAC will be administered 12 h (apixaban or dabigatran) or 24 h prior to PVI+LAAO (rivaroxaban). NOAC will be continued for 3 months. Given the exlusion of PDL\>=5 mm or DRT at 3 months, NOAC will be switched to chronic aspirin.

PROCEDURE

LAAO

Left atrial appendage occluder implantation (LAAO) will be performed via transseptal puncture under fluoroscopic and TEE guidance. LAAO implantation will comprise the use of either Amplatzer™ Amulet™ (Abbott) or WATCHMAN FLX™ (Boston Scientific) depending on local center's expertise. The procedure will be carried out within 4 weeks from randomization and will be performed during 3-day hospitalization in cardiology department. The procedure will be preceded by at least 4-week adequate anticoagulation with non-vitamin K antagonists (NOAC). The last dose of NOAC will be administered 12 h (apixaban or dabigatran) or 24 h prior to PVI+LAAO (rivaroxaban). NOAC will be continued for 3 months. Given the exlusion of PDL\>=5 mm or DRT at 3 months, NOAC will be switched to chronic aspirin.

DRUG

NOAC

Patients will be chronically treated with NOAC including apixaban (2x5 mg or 2x2.5 mg depending on the dose reduction regimen) or dabigatran (2x150 mg or 2x110 mg depending on the dose reduction regimen) or rivaroxaban (1x20 mg or 1x15 mg depending on the dose reduction regimen). The use vitamin K antagonists after the randomization is not allowed.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Upper-Silesian Medical Center
Katowice, Upper Silesia, Poland
Silesian Center for Heart Disease
Zabrze, Upper Silesia, Poland

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06212674), the sponsor (Medical University of Silesia), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06212674 clinical trial studying?

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 guidelin… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06212674?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06212674?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06212674. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06212674. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.