Single-stage pulmonary vein isolation with left atrial appendage occluder for people with recent ischemic stroke and atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, randomized phase 4 trial comparing a single-stage procedure that combines pulmonary vein isolation (PVI) and percutaneous left atrial appendage occlusion (LAAO) versus LAAO alone or ongoing non‑vitamin K oral anticoagulant (NOAC) therapy in patients with recent ischemic stroke and atrial fibrillation. Eligible participants have imaging-confirmed ischemic stroke 2–12 weeks before randomization, paroxysmal or persistent AF, and elevated thromboembolic risk, and must have anatomy suitable for percutaneous intervention. The trial will measure efficacy and safety outcomes including recurrent stroke, bleeding, AF control, and procedure-related complications. Results will be compared against historical evidence that LAAO can be non-inferior to vitamin K antagonists and that PVI provides symptomatic rhythm control.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Maciej T. Wybraniec, MD, PhD, Professor — Medical University of Silesia
• Study coordinator: Maciej T. Wybraniec, MD, PhD, Professor
• Email: mwybraniec@sum.edu.pl
• Phone: +48324796065

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.