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Active, Not Recruiting

NCT Number: NCT05986526

The PIFPAF-PFA Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cantonal Hospital Baden, Baden, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persistent atrial fibrillation documented on a 12 lead ECG, Holter monitor or implantable cardiac device within last 2 years of enrollment
  • Persistent atrial fibrillation is defined as a sustained episode lasting > 7 days
  • Candidate for ablation based on current atrial fibrillation guidelines
  • Continuous anticoagulation with Vitamin-K-Antagonists or a NOAC for ≥4 weeks prior to the ablation; or a transesophageal echocardiography and/or CT scan that excludes left atrial thrombus ≤48 hours before the ablation procedure
  • Age of 18 years or older on the date of informed consent
  • Signed informed consent

Exclusion criteria

  • Previous left atrial ablation or left atrial surgery
  • Left atrial diameter >60 mm in the parasternal long axis
  • Patients with paroxysmal atrial fibrillation
  • Patients with persistent atrial fibrillation lasting >3 years
  • AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery)
  • Intracardiac thrombus
  • Pre-existing pulmonary vein stenosis or pulmonary vein stent
  • Pre-existing hemidiaphragmatic paralysis
  • Contraindication to anticoagulation or radiocontrast materials
  • Prior mitral valve surgery
  • Severe mitral regurgitation or moderate/severe mitral stenosis
  • Myocardial infarction during the 3-month period preceding the consent date
  • Ongoing triple antithrombotic/anticoagulation therapy
  • Cardiac surgery during the 3-month interval preceding the informed consent date or scheduled cardiac surgery/ transcatheter aortic valve implantation
  • Significant congenital heart defect (including atrial septal defects or pulmonary vein abnormalities but not including a patent foramen ovale)
  • NYHA class III or IV congestive heart failure
  • Left ventricular ejection fraction (LVEF) <35%
  • Hypertrophic cardiomyopathy (wall thickness >1.5 cm)
  • Significant chronic kidney disease (eGFR <30 ml/min)
  • Uncontrolled hyperthyroidism
  • Cerebral ischemic event (stroke or TIA) during the 6-month interval preceding the informed consent date
  • Ongoing systemic infections
  • History of cryoglobulinemia
  • Cardiac amyloidosis
  • Pregnancy (to exclude pregnancy a blood test (HCG) is performed in women < 50 years before inclusion)
  • Life expectancy less than one year per physician opinion
  • Currently participating in any other clinical trial, which may confound the results of this trial
  • Unwilling or unable to comply fully with the study procedures and follow-up

Treatment and study plan

Pulmonary vein isolation without posterior wall ablation

Procedure

Pulmonary vein isolation with Pulsed field ablation without left atrial posterior wall ablation. At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring

Pulmonary vein isolation with posterior wall ablation

Procedure

Pulmonary vein isolation with Pulsed field ablation with left atrial posterior wall ablation. At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring

Primary outcomes

  1. Time to first recurrence of any atrial tachyarrhythmia day 91-365

    Time frame: Day 91-365 post-ablation

    Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)

Secondary outcomes

  1. Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between day 91-365 evaluated based on continuous ICM

    Time frame: Day 91-365 post-ablation

    Key secondary efficacy endpoint

  2. Treatment-emergent adverse events: Cardiac tamponade requiring drainage

    Time frame: Day 0-90 post-ablation

    Number of patients with cardiac tamponade requiring drainage after PVI

  3. Treatment-emergent adverse events: Persistent phrenic nerve palsy lasting >24 hours

    Time frame: Day 0-90 post-ablation

    Number of patients with persistent phrenic nerve palsy lasting >24 hours after PVI

  4. Treatment-emergent adverse events: Serious vascular complication requiring intervention

    Time frame: Day 0-90 post-ablation

    Number of patients with serious vascular complications requiring intervention after PVI

  5. Treatment-emergent adverse events: Stroke or TIA

    Time frame: Day 0-90 post-ablation

    Number of patients with stroke or TIA after PVI

  6. Treatment-emergent adverse events: Atrioesophageal fistula

    Time frame: Day 0-90 post-ablation

    Number of patients with atrioesophageal fistula after PVI

  7. Treatment-emergent adverse events: Death

    Time frame: Day 0-90 post-ablation

    Number of patients with fatal outcome/death after PVI

  8. Time to first recurrence of any atrial tachyarrhythmia day 0-365

    Time frame: Day 0-365 post-ablation

    Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)

  9. Time to first recurrence of any atrial tachyarrhythmia day 0-90

    Time frame: Day 0-90 post-ablation

    Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)

  10. Total procedure time

    Time frame: Day 0, during procedure

    Procedural endpoint; [min]

  11. Total left atrial indwelling time

    Time frame: Day 0, during procedure

    Procedural endpoint; [min]

  12. Total fluoroscopy time

    Time frame: Day 0, during procedure

    Procedural endpoint; [min]

  13. Total radiation dose

    Time frame: Day 0, during procedure

    Procedural endpoint; Calculated by multiplying the absorbed radiation dose (air kerma) by the cross-sectional area of the X-ray beam [cG*cm2]

  14. Change in hs-troponin on Day 1 post-ablation compared with pre-procedural hs-troponin

    Time frame: Pre-procedural (day -1 or day 0) to day 1 post-ablation

    Procedural endpoint; [ng/L]

  15. Post-ablation 3D electro-anatomical mapping: Proportion of isolated veins

    Time frame: Day 0, shortly after ablation

    Procedural endpoint

  16. Post-ablation 3D electro-anatomical mapping: Posterior wall ablation success rate

    Time frame: Day 0, shortly after ablation

    Procedural endpoint; experimental group only

  17. Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between day 0-90 evaluated based on continuous ICM

    Time frame: Day 0-90 post-ablation

    Secondary endpoint during follow-up

  18. Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between day 0-365 evaluated based on continuous ICM

    Time frame: Day 0-365 post-ablation

    Secondary endpoint during follow-up

  19. Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between day 365 until explantation or end of life (EOL) of the ICM

    Time frame: Day 365 post-ablation to explantation of ICM or end of life of ICM (up to 4 years after implantation of ICM)

    Secondary endpoint during follow-up

  20. Correlation of AF burden to symptoms and quality of life changes

    Time frame: Day 0-365 post-ablation

    Secondary endpoint during follow-up; Quality of life will be measured with the EQ-5D-5L questionnaire where higher scores mean better outcomes; Symptoms will be measured with the AFEQT (Atrial Fibrillation Effect on Quality-of-life) questionnaire where higher scores mean worse outcomes

  21. Time to first recurrence of atrial flutter/ atrial tachycardia day 91-365

    Time frame: Day 91-365 post-ablation

    Secondary endpoint during follow-up

  22. Time to first recurrence of atrial flutter/ atrial tachycardia day 0-90

    Time frame: Day 0-90 post-ablation

    Secondary endpoint during follow-up

  23. Time to first recurrence of atrial flutter/ atrial tachycardia day 0-365

    Time frame: Day 0-365 post-ablation

    Secondary endpoint during follow-up

  24. Time to first recurrence of persistent or paroxysmal atrial fibrillation day 91-365

    Time frame: Day 91-365 post-ablation

    Secondary endpoint during follow-up

  25. Time to first recurrence of persistent or paroxysmal atrial fibrillation day 0-90

    Time frame: Day 0-90 post-ablation

    Secondary endpoint during follow-up

  26. Time to first recurrence of persistent or paroxysmal atrial fibrillation day 0-365

    Time frame: Day 0-365 post-ablation

    Secondary endpoint during follow-up

  27. Average heart rate as recorded by the ICM in months 1, 2 and 3 after ablation

    Time frame: Months 1, 2 and 3 post-ablation

    Secondary endpoint during follow-up

  28. Hospital or emergency room admission due to atrial arrhythmia recurrence

    Time frame: Day 0-365 post-ablation

    Incidence rate

  29. Repeat ablation due to recurrence of atrial arrhythmias

    Time frame: Day 0-365 post-ablation

    Incidence rate

  30. Electrical cardioversion due to recurrence

    Time frame: Day 0-365 post-ablation

    Incidence rate

  31. Reinitiation or continuation of antiarrhythmic drug therapy day 91-365

    Time frame: Day 0-365 post-ablation

    Incidence rate

  32. Number of reconnected pulmonary veins evaluated during redo procedures

    Time frame: During redo procedures between day 1 to 36 months post-ablation

    Secondary endpoint during follow-up

  33. Sites of reconnection (anterior, posterior, superior, inferior) of the pulmonary veins evaluated during redo procedures

    Time frame: During redo procedures between day 1 to 36 months post-ablation

    Secondary endpoint during follow-up

  34. Size of antral scar area (cm²) of the pulmonary veins evaluated during redo procedures

    Time frame: During redo procedures between day 1 to 36 months post-ablation

    Secondary endpoint during follow-up

  35. Number of reconnected posterior walls evaluated during redo procedures

    Time frame: During redo procedures between day 1 to 36 months post-ablation

    Secondary endpoint during follow-up

  36. Sites of reconnection of the posterior wall evaluated during redo procedures

    Time frame: During redo procedures between day 1 to 36 months post-ablation

    Secondary endpoint during follow-up

  37. Size of the scar area (cm²) of the posterior wall evaluated during redo procedures

    Time frame: During redo procedures between day 1 to 36 months post-ablation

    Secondary endpoint during follow-up

  38. EQ-5D-5L Composite score month 3

    Time frame: Day 90 post-ablation

    Quality of life wil be measured with the EQ-5D-5L questionnaire where higher scores mean better outcomes. Composite score month 3.

  39. EQ-5D-5L Composite score month 12

    Time frame: Day 365 post-ablation

    Quality of life wil be measured with the EQ-5D-5L questionnaire where higher scores mean better outcomes. Composite score month 12.

  40. EQ-5D-5L Visual analogue scale month 3

    Time frame: Day 90 post-ablation

    Quality of life wil be measured with the EQ-5D-5L questionnaire where higher scores mean better outcomes. Visual analogue scale month 3.

  41. EQ-5D-5L Visual analogue scale month 12

    Time frame: Day 365 post-ablation

    Quality of life wil be measured with the EQ-5D-5L questionnaire where higher scores mean better outcomes. Visual analogue scale month 12.

  42. AFEQT month 3

    Time frame: Day 90 post-ablation

    Quality of life wil be measured with the AFEQT questionnaire.

  43. AFEQT month 12

    Time frame: Day 365 post-ablation

    Quality of life wil be measured with the AFEQT questionnaire.

  44. Stroke or transient ischemic attack day 0-365

    Time frame: Day 0-365 post-ablation

    Incidence rate

  45. All-cause death day 0-365

    Time frame: Day 0-365 post-ablation

    Incidence rate

  46. Time to first episode of atrial tachyarrhythmia day 91-365 lasting ≥1 hour

    Time frame: Day 91-365 post-ablation

    Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)

  47. Time to first episode of atrial tachyarrhythmia day 91-365 lasting ≥6 hour

    Time frame: Day 91-365 post-ablation

    Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)

  48. Time to first episode of atrial tachyarrhythmia day 91-365 lasting ≥1 day

    Time frame: Day 91-365 post-ablation

    Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)

  49. Time to first episode of atrial tachyarrhythmia day 91-365 lasting ≥2 days

    Time frame: Day 91-365 post-ablation

    Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)

  50. Time to first episode of atrial tachyarrhythmia day 91-365 lasting ≥7 days

    Time frame: Day 91-365 post-ablation

    Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)

Other outcomes

  1. Time to first recurrence of any atrial tachyarrhythmia in patients with versus without left atrial posterior wall scar

    Time frame: Day 91-365 post-ablation

    Subgroup analysis; Scar is based on the 3D pre-ablation voltage map at baseline

  2. Time to first recurrence of any atrial tachyarrhythmia in female versus male patients

    Time frame: Day 91-365 post-ablation

    Subgroup analysis

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Pulmonary Vein Isolation With Pulsed-Field Ablation With Versus Without Posterior Wall Ablation in Patients With Symptomatic Persistent Atrial Fibrillation - A Multi-Center Randomized Clinical Trial: The PIFPAF-PFA Study

Acronym: PIFPAF-PFA

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Aug 14, 2023
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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