Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure in AF Patients

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 post-market study collects real-world data on patients undergoing atrial fibrillation ablation with the FARAPULSE pulsed field ablation system followed by left atrial appendage closure with a WATCHMAN FLX device in the same procedure. Eligible patients are treated per their physician’s judgment as part of standard care, and data are gathered from approved investigational centers. The protocol specifies concomitant PFA and LAAC in a single interventional case, with follow-up testing as required by the study. Enrollment is limited to adults able to provide informed consent who meet the device indications and institutional requirements. The sponsor is Boston Scientific Corporation, with participating sites in Europe (Belgium and Croatia).

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN FLX™ Pro or WATCHMAN FLX™ for LAAC, per physician medical judgement and as per hospitals' standard of care.
2. Subjects who are willing and able to provide informed consent.
3. Subjects who are willing and able to participate in all testing associated with this clinical study at an approved investigational center.
4. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

1. Subjects who underwent prior AF ablation procedure.
2. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes.
3. Already surgically closed or otherwise excluded LAA.
4. The LAA anatomy does not accommodate a Closure Device.
5. Known or suspected atrial myxoma.
6. Presence of intracardiac thrombus\*.
7. Subjects with a current interatrial baffle or patch, history of atrial septal repair or has an atrial septal defect (ASD) / patent foramen ovale (PFO) device.
8. Subjects with a presence of a mechanical valve prosthesis in any position.
9. Subjects with a myocardial infarction within 90 days prior to enrollment.
10. Subjects had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within 90 days prior to enrollment.
11. Any planned electrical cardioversion within 30 days following LAAC device implant.
12. Subjects with a known inability to obtain vascular access.
13. Subjects with any contraindication to percutaneous catheterization procedure (e.g., patient size does not accommodate required catheters, ventriculotomy or atriotomy) or congenital abnormalities (severe rotational anomalies of the heart or great vessels) are present.
14. Subjects with any active conditions (e.g. infection, bleeding disorder, unstable angina).
15. Subjects with any contraindications to short term use of anticoagulation therapy for conditions different from atrial fibrillation.
16. Subjects who are pregnant or planning to be pregnant.
17. Subjects with a life expectancy of ≤ 1 year per investigator's opinion.
18. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be reviewed by the sponsor to determine eligibility.

Where it's running

• AZORG - Hospital
  Aalst, Belgium Recruiting
• UZ Brussel (AZ VUB)
  Brussels, Belgium Recruiting
• Klinicki bolnicki centar Zagreb
  Zagreb, Croatia Recruiting
• CHRU de Clermont-Ferrand
  Clermont-Ferrand, France Recruiting
• Centre Cardiologique du Nord
  Saint-Denis, France Recruiting
• Clinique Pasteur - Toulouse
  Toulouse, France Recruiting

Study contacts

• Study coordinator: Katherine A Beattie, Sr. Clinical Trial Manager, RN
• Email: Katherine.beattie@bsci.com
• Phone: 1-800-CARDIAC

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Factors Linked to Slow Heart Rate After Pulsed Field Ablation for Atrial Fibrillation

  This study looks for factors that might cause bradycardia during the hospital stay after AF ablation using pulsed field technology.

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• Pulsed Field Ablation Outcomes in Atrial Fibrillation: Randomized Comparison to Traditional Ablation

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• Tailored lower‑intensity blood thinner plan after left atrial appendage closure to prevent stroke

  This project tests whether people with non‑valvular atrial fibrillation who get a left atrial appendage closure can stop blood thinners after taking low‑dose apixaban (2.5 mg twice daily) for 3 months, compared with people who stay on standard‑dose DOACs.

  Recruiting National Medical Research Center for Therapy and Preventive Medicine · Moscow · NCT07575867

• Electroporation versus Radiofrequency Ablation Guided by 3D Imaging for Repeat Atrial Fibrillation

  This trial tests whether pulsed field electroporation or standard radiofrequency ablation works better and safer for people having a repeat catheter ablation for recurrent atrial fibrillation.

  Recruiting Wroclaw Medical University · Wroclaw · NCT07141745

• Comparing FARAPULSE and FARAWAVE Nav catheters during pulmonary vein isolation for atrial fibrillation

  This test will see if the FARAWAVE Nav catheter's built-in mapping can be used instead of pre-procedure CT scans for adults having pulmonary vein isolation for atrial fibrillation.

  Recruiting Cardiocentro Ticino · Lugano, Canton Ticino · NCT07130773

• Pulsed field ablation registry for atrial arrhythmias in Poland.

  This project will collect information to see how well pulsed field ablation works and how safe it is for people in Poland having ablation for atrial fibrillation, atrial flutter, or atrial tachycardia.

  Recruiting Wroclaw Medical University · Wroclaw, Lower Silesian Voivodeship · NCT07109141

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.