The PIFPAF-PFA Study

Last updated: February 17, 2025
Sponsor: Insel Gruppe AG, University Hospital Bern
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Arrhythmia

Dysrhythmia

Chest Pain

Treatment

Pulmonary vein isolation without posterior wall ablation

Pulmonary vein isolation with posterior wall ablation

Clinical Study ID

NCT05986526
2023-00885
  • Ages > 18
  • All Genders

Study Summary

Pulmonary vein isolation (PVI) is very effective for rhythm control in patients with paroxysmal atrial fibrillation (AF), but less successful in patients with persistent AF. Adding posterior wall ablation (PWA) to PVI is among the most promising ablation strategies to improve arrhythmiafree outcome in patients with persistent AF. Patients with left atrial posterior wall scar may benefit most from adding PWA to PVI. With previous ablation technology, posterior wall isolation (PWI) was difficult to achieve and increased the risk of procedural complications. With pulsed-field ablation (PFA), a technology is now available which is both very effective and safe for complete ablation of the posterior wall. The aim of this trial therefore is to compare the efficacy and procedural safety of two ablation strategies for the treatment of persistent AF using PFA: PVI only versus PVI with added PWA. The endpoint of atrial arrhythmia recurrence within 12 months will be assessed by an implantable cardiac monitor (ICM) with remote monitoring capabilities.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Persistent atrial fibrillation documented on a 12 lead ECG, Holter monitor orimplantable cardiac device within last 2 years of enrollment

  2. Persistent atrial fibrillation is defined as a sustained episode lasting > 7 days

  3. Candidate for ablation based on current atrial fibrillation guidelines

  4. Continuous anticoagulation with Vitamin-K-Antagonists or a NOAC for ≥4 weeks priorto the ablation; or a transesophageal echocardiography and/or CT scan that excludesleft atrial thrombus ≤48 hours before the ablation procedure

  5. Age of 18 years or older on the date of informed consent

  6. Signed informed consent

Exclusion

Exclusion Criteria:

  1. Previous left atrial ablation or left atrial surgery

  2. Left atrial diameter >60 mm in the parasternal long axis

  3. Patients with paroxysmal atrial fibrillation

  4. Patients with persistent atrial fibrillation lasting >3 years

  5. AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery)

  6. Intracardiac thrombus

  7. Pre-existing pulmonary vein stenosis or pulmonary vein stent

  8. Pre-existing hemidiaphragmatic paralysis

  9. Contraindication to anticoagulation or radiocontrast materials

  10. Prior mitral valve surgery

  11. Severe mitral regurgitation or moderate/severe mitral stenosis

  12. Myocardial infarction during the 3-month period preceding the consent date

  13. Ongoing triple antithrombotic/anticoagulation therapy

  14. Cardiac surgery during the 3-month interval preceding the informed consent date orscheduled cardiac surgery/ transcatheter aortic valve implantation

  15. Significant congenital heart defect (including atrial septal defects or pulmonaryvein abnormalities but not including a patent foramen ovale)

  16. NYHA class III or IV congestive heart failure

  17. Left ventricular ejection fraction (LVEF) <35%

  18. Hypertrophic cardiomyopathy (wall thickness >1.5 cm)

  19. Significant chronic kidney disease (eGFR <30 ml/min)

  20. Uncontrolled hyperthyroidism

  21. Cerebral ischemic event (stroke or TIA) during the 6-month interval preceding theinformed consent date

  22. Ongoing systemic infections

  23. History of cryoglobulinemia

  24. Cardiac amyloidosis

  25. Pregnancy (to exclude pregnancy a blood test (HCG) is performed in women < 50 yearsbefore inclusion)

  26. Life expectancy less than one year per physician opinion

  27. Currently participating in any other clinical trial, which may confound the resultsof this trial

  28. Unwilling or unable to comply fully with the study procedures and follow-up

Study Design

Total Participants: 206
Treatment Group(s): 2
Primary Treatment: Pulmonary vein isolation without posterior wall ablation
Phase:
Study Start date:
November 13, 2023
Estimated Completion Date:
February 13, 2028

Connect with a study center

  • Cantonal Hospital Baden

    Baden,
    Switzerland

    Site Not Available

  • University Hospital Basel

    Basel,
    Switzerland

    Site Not Available

  • Inselspital, University Hospital Bern

    Bern, 3010
    Switzerland

    Site Not Available

  • University Hospital Lausanne

    Lausanne, 1011
    Switzerland

    Site Not Available

  • Cantonal Hospital St. Gallen

    St. Gallen,
    Switzerland

    Site Not Available

  • University Hospital Zürich

    Zürich,
    Switzerland

    Site Not Available

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