AzTrials
AzTrials

Ischemic StrokePhase 4PILOS-AFNCT06212674

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

A Phase 4 study testing PVI + LAAO, single stage, LAAO and NOAC in people with Ischemic Stroke and Atrial Fibrillation, run by Medical University of Silesia at 2 sites in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ischemic Stroke, Atrial Fibrillation
What is being tested?
PVI + LAAO, single stage, LAAO and NOAC
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
2 sitesPoland
Study dates
31 Oct 2025to 31 Oct 2030
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • CHA2DS2-VA risk score ≥2 points
  • Left atrial anatomy (atrial septum, pulmonary vein orifices and left atrial appendage) suitable for intervention (PVI + LAAO or LAAO)
  • ≥ 4 weeks of adequate anticoagulant treatment in the preceding period
  • no anatomical or functional contraindications and patient consent for transesophageal echocardiography (TEE)
Show all 10Show fewer
  • Based on the aforementioned inclusion criteria, patients who can be classified into 3. groups will be enrolled in the study:
  • patients with atrial fibrillation who have been adequately treated with anticoagulation (VKA/NOAC) and have had an ischemic stroke
  • patients without prior history of atrial fibrillation and without anticoagulation who have an ischemic stroke and the atrial fibrillation is clinically overt (de novo)
  • 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 cannot join

  • 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:
  • history of mechanical valve implantation
  • history of mitral biological valve implantation within 3 months prior to randomization
Show all 39Show fewer
  • history of deep vein thrombosis or pulmonary embolism within preceding 6 months or indication for chronic anticoagulation
  • genetically or immunologically confirmed thrombophilia
  • contraindications to NOAC treatment:
  • eGFR ≤15 ml/min/1.73 m2
  • mechanical valve prosthesis
  • moderate or severe mitral valve stenosis of rheumatic etiology
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Maciej T. Wybraniec, MD, PhD, Professor contact

+48324796065

mwybraniec@sum.edu.pl

Krystian Wita, MD, PhD, Professor contact

+48323598953

dl@gcm.pl

Poland2 sites, 2 recruiting

  • Upper-Silesian Medical Center

    Katowice, Upper Silesia, 40-635

    Maciej T Wybraniec, MD, PhD, Professor, +48324796065, mwybraniec@sum.edu.pl

    Krystian Wita, MD, PhD, Professor, +48323598953, dl@gcm.pl

    Recruiting

  • Silesian Center for Heart Disease

    Zabrze, Upper Silesia, 41-800

    Zbigniew Kalarus, MD, PhD, Professor, +48324793682, sek.KD1@sccs.pl

    Recruiting

Other trials in Poland

About this study

Official title: 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)

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.

Read more

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.

Being tested
PVI + LAAO, single stage, LAAO, NOAC
Keywords
Pulmonary vein isolation, Occluder implantation, PILOS, PILOS-AF, LAA ocludder implantation, ischemic stroke, atrial fibrillation
Medical subject headings
Ischemic Stroke, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PVI + LAAO, single stageProcedure or surgery

    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.

  • LAAOProcedure or surgery

    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.

  • NOACDrug

    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.

Study groups in NCT06212674
Study groupRoleWhat they receive
PVI+LAAOExperimental80 patients
Receives: Procedure: PVI + LAAO, single stage
LAAOExperimental80 patients
Receives: Procedure: LAAO
NOACActive comparator80 patients
Receives: Drug: NOAC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of cardiovascular deaths, ischemic stroke, transient ischemic attack (TIA), systemic embolism or major bleeding unrelated to the procedure, including intracranial bleeding.

    The primary composite endpoint comprises the rate of cardiovascular deaths, ischemic stroke, transient ischemic attack (TIA), systemic embolism or major bleeding unrelated to the procedure, including intracranial bleeding.

    Measured: 12 months

Secondary outcomes (20)

  1. The rate of cardiovascular deaths, ischemic stroke, transient ischemic attack (TIA), systemic embolism or major bleeding unrelated to the procedure, including intracranial bleeding.

    The composite primary endpoint comprises the rate of cardiovascular deaths, ischemic stroke, transient ischemic attack (TIA), systemic embolism or major bleeding unrelated to the procedure, including intracranial bleeding.

    Measured: 3, 24 and 48 months

  2. The rate of cardiovascular death

    Evaluation of the rate of cardiovascular death

    Measured: 3, 6, 12, 24, 36, 48 months

  3. The rate of ischemic stroke and/or TIA and/or systemic embolism

    Evaluation of the rate of ischemic stroke and/or TIA and/or systemic embolism

    Measured: 3, 6, 12, 24, 36, 48 months

  4. The rate of major non-procedural bleeding

    Evaluation of the rate of major non-procedural bleeding defined by ISTH

    Measured: 3, 6, 12, 24, 36, 48 months

  5. The rate of all-cause death

    Evaluation of the rate of all-cause death

    Measured: 3, 6, 12, 24, 36, 48 months

  6. The proportion of procedural feasibility

    Evaluation of the proportion of procedures completed according to prespecified allocation

    Measured: Immediately after intervention

  7. AF burden on Holter ECG monitoring

    Proportion of time during 24, 7-day or 30-day monitoring with AF rhythm evaluated by prolonged surface ECG monitoring system.

    Measured: 12 and 48 months

  8. Evaluation of the freedom from AF

    Lack of AF episodes on 24-hour, 7-day or 30 day ECG monitoring

    Measured: 12 and 48 months

  9. Change of symptomatic class according to NYHA classification

    Evaluation of the change of symptomatic class according to NYHA classification

    Measured: 3, 6, 12, 24, 36 and 48 months

  10. Change of symptomatic class according to EHRA classification

    Evaluation of the change of symptomatic class according to EHRA classification

    Measured: 3, 6, 12, 24, 36, 48 months

  11. Evaluation of the change of left ventricular ejection fraction based on transthoracic echocardiography using biplane Simpson's method

    Evaluation of the change of left ventricular ejection fraction based on transthoracic echocardiography using biplane Simpson's method

    Measured: 12, 48 months

  12. Evaluation of the change of E/e' based on transthoracic echocardiography

    Evaluation of the change of E/e' based on transthoracic echocardiography

    Measured: 12, 48 months

  13. Evaluation of the change of GLS LA strain based on transthoracic echocardiography

    Evaluation of the change of GLS LA strain based on transthoracic echocardiography

    Measured: 12, 48 months

  14. Evaluation of the change of segmental LA strain based on transthoracic echocardiography

    Evaluation of the change of segmental LA strain based on transthoracic echocardiography

    Measured: 12, 48 months

  15. Change of cardiac biomarker concentration using ELISA method

    Change of cardiac biomarker concentration using ELISA method:

    • NT-proBNP
    • ST-2
    • galectin-3

    Measured: 3 and 12 months

  16. Evaluation of the change of quality of life reflected by EQ-5D questionnaire

    Evaluation of the change of quality of life reflected by EQ-5D questionnaire

    Measured: 3, 12 and 48 months

  17. Evaluation of the change of quality of life reflected by KCCQ questionnaire

    Evaluation of the change of quality of life reflected by KCCQ questionnaire

    Measured: 3, 12 and 48 months

  18. Evaluation of the change of quality of life reflected by SF-36 questionnaire

    Evaluation of the change of quality of life reflected by SF-36 questionnaire

    Measured: 3, 12 and 48 months

  19. Evaluation of the presence of PDL >=5 mm on transesophageal echocardiography at 3 months

    Evaluation of the presence of peri-device leak of >=5 mm on transesophageal echocardiography at 3 months

    Measured: 3 months

  20. Evaluation of the presence of device-related thrombus on transesophageal echocardiography at 3 months

    Evaluation of the presence of device-related thrombus on transesophageal echocardiography at 3 months

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2024
  2. Study start31 Oct 2025
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion31 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06212674
Sponsor's protocol ID
PILOS-AF_v3.0
Other IDs
2023/ABM/01/00074-00
Acronym
PILOS-AF
Status last verified
Apr 2026
First submitted
19 Dec 2023
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It is forbidden by the Ethics Committee.

Publications

  • Wybraniec MT, Hoffmann A, Bochenek T, Lelek M, Wita M, Szydlo K, Lasek-Bal A, Gasior M, Kalarus Z, Ptaszynski P, Kazmierczak J, Mizia-Stec K, Wita K. Single-stage pulmonary vein isolation combined with percutaneous implantation of left atrial appendage occluder in patients with recent onset ischemic stroke and atrial fibrillation (PILOS-AF): A study protocol of randomized controlled trial. Cardiol J. 2025;32(4):416-424. doi: 10.5603/cj.104167. Epub 2025 Jun 3. No abstract available.

    PubMed 40459054

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PVI + LAAO, single stage, LAAO and NOAC in people with Ischemic Stroke and Atrial Fibrillation, run by Medical University of Silesia at 2 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maciej T. Wybraniec, MD, PhD, Professor (+48324796065, mwybraniec@sum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of cardiovascular deaths, ischemic stroke, transient ischemic attack (TIA), systemic embolism or major bleeding unrelated to the procedure, including intracranial bleeding. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06212674, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in