The PIFPAF-PFA Study

NCT05986526 | Active Not Recruiting DMC

• 1 other identifier: 2023-00885
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Persistent Atrial Fibrillation

Keywords

Pulmonary vein isolation; Pulsed field ablation; Left atrial posterior wall isolation

Outcome Measures

Primary Outcomes (1)

• Time to first recurrence of any atrial tachyarrhythmia

  Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial flutter \[AFL\] or atrial tachycardia \[AT\]) between days 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)

  Days 91 to 365 post-ablation

Secondary Outcomes (40)

• Incidence of treatment-emergent adverse events: Cardiac tamponade

  Days 0 to 90 post-ablation

• Incidence of treatment-emergent adverse events: Persistent phrenic nerve palsy

  Days 0 to 90 post-ablation

• Incidence of treatment-emergent adverse events: Serious vascular complication

  Days 0 to 90 post-ablation

• Incidence of treatment-emergent adverse events: Stroke or TIA

  Days 0 to 90 post-ablation

• Incidence of treatment-emergent adverse events: Atrioesophageal fistula

  Days 0 to 90 post-ablation

Study Arms (2)

Pulmonary vein isolation without posterior wall ablation

ACTIVE COMPARATOR

Pulmonary vein isolation without left atrial posterior wall ablation

Procedure: Pulmonary vein isolation without posterior wall ablation

Pulmonary vein isolation with posterior wall ablation

ACTIVE COMPARATOR

Pulmonary vein isolation with left atrial posterior wall ablation

Procedure: Pulmonary vein isolation with posterior wall ablation

Interventions

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

Pulmonary vein isolation with posterior wall ablation

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 without posterior wall ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (6)

Cantonal Hospital Baden

Baden, Switzerland

Location

University Hospital Basel

Basel, Switzerland

Location

Inselspital, University Hospital Bern

Bern, 3010, Switzerland

Location

University Hospital Lausanne

Lausanne, 1011, Switzerland

Location

Cantonal Hospital St. Gallen

Sankt Gallen, Switzerland

Location

University Hospital Zürich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurent Roten, MD

  Inselspital, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 14, 2023
• Study Start: November 13, 2023
• Primary Completion: February 13, 2026
• Study Completion (Estimated): February 13, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CH (6)