Comparison of two ablation strategies for the treatment of persistent atrial fibrillation

Switzerland (ICTRP)

ICTRP Trial ID
NCT05986526 (ICTRP)

Official title (approved by ethics committee)
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 (BASEC)

Academic 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 (ICTRP)

Public title
The PIFPAF-PFA Study (ICTRP)

Disease under investigation
Persistent Atrial Fibrillation (ICTRP)

Intervention under investigation
Procedure: Pulmonary vein isolation without posterior wall ablationProcedure: Pulmonary vein isolation with posterior wall ablation (ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Inclusion/Exclusion criteria
Inclusion Criteria:

1. Persistent atrial fibrillation documented on a 12 lead ECG, Holter monitor or
implantable 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 prior
to the ablation or a transesophageal echocardiography and/or CT scan that excludes
left 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 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 or
scheduled cardiac surgery/ transcatheter aortic valve implantation

15. Significant congenital heart defect (including atrial septal defects or pulmonary
vein 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 the
informed 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 years
before inclusion)

26. Life expectancy less than one year per physician opinion

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

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

not available

Primary and secondary end points
Time to first recurrence of any atrial tachyarrhythmia (ICTRP)

Incidence of treatment-emergent adverse events: Cardiac tamponade;Incidence of treatment-emergent adverse events: Persistent phrenic nerve palsy;Incidence of treatment-emergent adverse events: Serious vascular complication;Incidence of treatment-emergent adverse events: Stroke or TIA;Incidence of treatment-emergent adverse events: Atrioesophageal fistula;Incidence of treatment-emergent adverse events: Death;Total procedure time;Total left atrial indwelling time;Total fluoroscopy time;Total radiation dose;Change in hs-Troponin on day 1 post-ablation;Pre-ablation 3D electro-anatomical mapping: Number of participants with scar as a region that demonstrated reproducibly an area of > 0.5�0.5 cm on the posterior wall with voltage less than 0.5 mV;Post-ablation 3D electro-anatomical mapping: Proportion of isolated veins;Post-ablation 3D electro-anatomical mapping: Proportion of isolated carinas;Post-ablation 3D electro-anatomical mapping: Lesion size;Post-ablation 3D electro-anatomical mapping: Posterior wall ablation success rate;Time to first recurrence of any atrial tachyarrhythmia in patients with versus without left atrial posterior wall scar;Time to first recurrence of any atrial tachyarrhythmia in patients with left atrial posterior wall scar and posterior wall ablation versus without posterior wall ablation;Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between days 0-90 evaluated based on continuous ICM;Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between days 91-365 evaluated based on continuous ICM;Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between days 365 until explantation or end of life (EOL) of the ICM;Correlation of AF burden to symptoms and quality of life changes;Reduction of percentage of time with cardiac arrhythmia (AF burden) by > 90% post ablation procedure;Comparison of the prevalence of the type of arrhythmia recurrence during follow-up being AF or organized atrial arrhythmias (AFL or AT);Time to first recurrence of atrial tachyarrhythmia between days 91 and 365 evaluated based on continuous ICM in patients with presence of scar on the PW based on the preablation voltage map versus patients with no scar on the PW;Number of participants with persistent or paroxysmal AF during follow-up;Average heart rate as recorded by the ICM in months 1, 2 and 3 after ablation;Proportion of patients admitted to the hospital or emergency room because of documented recurrence of atrial arrhythmias;Proportion of patients undergoing a repeat ablation procedure because of documented recurrence of atrial arrhythmias;Number of participants reinitiating of antiarrhythmic drugs during follow-up;Number of participants with electrical cardioversion during follow-up;Number of reconnected pulmonary veins evaluated during redo procedures;Sites of reconnection (anterior, posterior, superior, inferior) of the pulmonary veins evaluated during redo procedures;Size of antral scar area (cm�) of the pulmonary veins evaluated during redo procedures;Number of reconnected posterior walls evaluated during redo procedures;Sites of reconnection of the posterior wall evaluated during redo procedures;Size of the scar area (cm�) of the posterior wall evaluated during redo procedures;Evolution of Quality of Life after 3 and 12 months;Number of participants with stroke including TIA after 3, 12, 24 and 36 months;Number of participants with cardiovascular or non-cardiovascular death after 3, 12, 24 and 36 months (ICTRP)

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
not available

Additional contacts
Laurent Roten, MD;Laurent Roten, MD, Laurent.Roten@insel.ch, +41 31 632 52 63, Inselspital, University Hospital Bern, (ICTRP)

Secondary trial IDs
2023-00885 (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05986526 (ICTRP)